{
    "info": {
        "nct_id": "NCT05683691",
        "official_title": "Prospective, Multicenter, Single-Arm Study of VanquishTM Water Vapor Ablation for PrOstate CanceR",
        "inclusion_criteria": "1. ≥50 years of age; with life expectancy of ≥10 years\n2. 20-80 cc prostate size determined by MRI Central Imaging\n3. ≤15 ng/ml PSA\n4. Cancer stage less than or equal to T2c\n5. Within 12 months prior to signing consent have had a multiparametric MRI. Within 6 months prior to signing consent, have undergone a multiparametric MRI software guided fusion biopsy of the prostate (transrectal or transperineal). This must include a standard sector biopsy obtaining a minimum of 10 cores.\n\n   * <15mm diameter of qualifying lesion as measure by greatest diameter\n6. Subject is willing and able to adhere to specific protocol visits and required testing throughout study\n7. Is geographically stable and near the site or able and willing to travel back to site for follow-up visits involving diagnostic tests or treatment\n8. Able and willing to provide written consent to participate in the study.\n9. Subject is willing and able to be treated within 180 days after signing consent.\nHealthy volunteers allowed\nMust be MALE\nMust have minimum age of 50 Years",
        "exclusion_criteria": "1. Patients with >GGG3 cores anywhere in the prostate\n2. MRI evidence of extracapsular extension of cancer (MRI read as \"definite\", \"frank\" or \"gross\" ECE)\n3. All MRI Central Imaging confirmed PI-RADS 5 lesions\n4. All MRI Central Imaging confirmed additional PI-RADS 4 lesions.\n5. Contraindications to MRI\n6. Subjects with an installed pacemaker or other potentially electrically conductive implants implanted within 200mm (8 inches) of the procedure area. Implants that are within 200mm (8 inches) and can be turned off for the duration of the study procedure are acceptable.\n7. Any prior surgery, intervention, or minimally invasive therapy, (MIST) for the prostate cancer or bladder neck.\n8. Treated within the past 5 years for genital cancer\n9. Presence of any urethral or prostatic condition that precludes water vapor ablation per Instructions for Use\n10. Currently taking medications that have hormonal effects on the prostate or PSA, such as: 5 alpha reductase inhibitors (if on for <6 months, 6-month washout), Androgen blockers, Luteinizing hormone-releasing hormone (LHRH) agonists or antagonists (12-month washout), or Testosterone supplementation (3-month washout)\n11. Active urinary tract infection. Subjects with an active infection who can be treated and re-tested with a negative result within the screening window are acceptable.\n12. Active or clinically chronic prostatitis or granulomatous prostatitis\n13. Treated within the past 5 years for a lower and/or upper urinary tract malignancy.\n14. Any previous treatment for prostate cancer.\n15. Any rectal pathology, anomaly or previous treatment that could change properties of rectal wall or insertion and use of TRUS\n16. Unable to stop taking antiplatelet medications or other blood thinning agents\n17. Known allergy to nickel\n18. Allergic to medication required by the study such as MRI contrast or anesthesia\n19. Any significant medical history that would pose an unreasonable risk or make the subject unsuitable for the study\n20. Any cognitive or psychiatric condition that interferes with or precludes direct and accurate communication with the study Investigator regarding the study or affects the ability to complete the study quality of life questionnaires\n21. Subject currently participating in other premarket investigational studies unless approved by Sponsor in writing\n22. Subject is considered vulnerable such as incarcerated or cognitively impaired.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. ≥50 years of age; with life expectancy of ≥10 years",
            "criterions": [
                {
                    "exact_snippets": "≥50 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "life expectancy of ≥10 years",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 10,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. 20-80 cc prostate size determined by MRI Central Imaging",
            "criterions": [
                {
                    "exact_snippets": "20-80 cc prostate size determined by MRI Central Imaging",
                    "criterion": "prostate size",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 20,
                                        "unit": "cc"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 80,
                                        "unit": "cc"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. ≤15 ng/ml PSA",
            "criterions": [
                {
                    "exact_snippets": "≤15 ng/ml PSA",
                    "criterion": "PSA level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 15,
                                "unit": "ng/ml"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Cancer stage less than or equal to T2c",
            "criterions": [
                {
                    "exact_snippets": "Cancer stage less than or equal to T2c",
                    "criterion": "cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "T"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Within 12 months prior to signing consent have had a multiparametric MRI. Within 6 months prior to signing consent, have undergone a multiparametric MRI software guided fusion biopsy of the prostate (transrectal or transperineal). This must include a standard sector biopsy obtaining a minimum of 10 cores.",
            "criterions": [
                {
                    "exact_snippets": "Within 12 months prior to signing consent have had a multiparametric MRI.",
                    "criterion": "multiparametric MRI",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 12,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Within 6 months prior to signing consent, have undergone a multiparametric MRI software guided fusion biopsy of the prostate",
                    "criterion": "multiparametric MRI software guided fusion biopsy of the prostate",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 6,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "This must include a standard sector biopsy obtaining a minimum of 10 cores.",
                    "criterion": "standard sector biopsy",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 10,
                                "unit": "cores"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* <15mm diameter of qualifying lesion as measure by greatest diameter",
            "criterions": [
                {
                    "exact_snippets": "<15mm diameter of qualifying lesion",
                    "criterion": "qualifying lesion",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": "<",
                                "value": 15,
                                "unit": "mm"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Subject is willing and able to adhere to specific protocol visits and required testing throughout study",
            "criterions": [
                {
                    "exact_snippets": "Subject is willing and able to adhere to specific protocol visits",
                    "criterion": "adherence to protocol visits",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Subject is willing and able to adhere to ... required testing throughout study",
                    "criterion": "adherence to required testing",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Is geographically stable and near the site or able and willing to travel back to site for follow-up visits involving diagnostic tests or treatment",
            "criterions": [
                {
                    "exact_snippets": "Is geographically stable",
                    "criterion": "geographical stability",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "near the site",
                    "criterion": "proximity to site",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "able and willing to travel back to site",
                    "criterion": "willingness and ability to travel",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Able and willing to provide written consent to participate in the study.",
            "criterions": [
                {
                    "exact_snippets": "Able and willing to provide written consent",
                    "criterion": "consent to participate",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "form",
                            "expected_value": "written"
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Subject is willing and able to be treated within 180 days after signing consent.",
            "criterions": [
                {
                    "exact_snippets": "Subject is willing and able to be treated",
                    "criterion": "willingness and ability to be treated",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "within 180 days after signing consent",
                    "criterion": "treatment timeline",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": {
                                "operator": "<=",
                                "value": 180,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must be MALE",
            "criterions": [
                {
                    "exact_snippets": "Must be MALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "male"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 50 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 50 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Patients with >GGG3 cores anywhere in the prostate",
            "criterions": [
                {
                    "exact_snippets": "Patients with >GGG3 cores anywhere in the prostate",
                    "criterion": "GGG cores in the prostate",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "GGG cores"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. MRI evidence of extracapsular extension of cancer (MRI read as \"definite\", \"frank\" or \"gross\" ECE)",
            "criterions": [
                {
                    "exact_snippets": "MRI evidence of extracapsular extension of cancer",
                    "criterion": "extracapsular extension of cancer",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": "MRI"
                        }
                    ]
                },
                {
                    "exact_snippets": "MRI read as \"definite\", \"frank\" or \"gross\" ECE",
                    "criterion": "MRI read",
                    "requirements": [
                        {
                            "requirement_type": "interpretation",
                            "expected_value": [
                                "definite",
                                "frank",
                                "gross"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. All MRI Central Imaging confirmed PI-RADS 5 lesions",
            "criterions": [
                {
                    "exact_snippets": "MRI Central Imaging confirmed PI-RADS 5 lesions",
                    "criterion": "PI-RADS lesions",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "MRI Central Imaging"
                        },
                        {
                            "requirement_type": "PI-RADS score",
                            "expected_value": {
                                "operator": "=",
                                "value": 5,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. All MRI Central Imaging confirmed additional PI-RADS 4 lesions.",
            "criterions": [
                {
                    "exact_snippets": "MRI Central Imaging confirmed additional PI-RADS 4 lesions",
                    "criterion": "PI-RADS lesions",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "PI-RADS score",
                            "expected_value": {
                                "operator": "=",
                                "value": 4,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Contraindications to MRI",
            "criterions": [
                {
                    "exact_snippets": "Contraindications to MRI",
                    "criterion": "MRI contraindications",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Subjects with an installed pacemaker or other potentially electrically conductive implants implanted within 200mm (8 inches) of the procedure area. Implants that are within 200mm (8 inches) and can be turned off for the duration of the study procedure are acceptable.",
            "criterions": [
                {
                    "exact_snippets": "installed pacemaker",
                    "criterion": "pacemaker",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "other potentially electrically conductive implants",
                    "criterion": "electrically conductive implants",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "implanted within 200mm (8 inches) of the procedure area",
                    "criterion": "implant location",
                    "requirements": [
                        {
                            "requirement_type": "distance from procedure area",
                            "expected_value": {
                                "operator": "<=",
                                "value": 200,
                                "unit": "mm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Implants that are within 200mm (8 inches) and can be turned off for the duration of the study procedure are acceptable",
                    "criterion": "implant functionality",
                    "requirements": [
                        {
                            "requirement_type": "ability to be turned off",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Any prior surgery, intervention, or minimally invasive therapy, (MIST) for the prostate cancer or bladder neck.",
            "criterions": [
                {
                    "exact_snippets": "Any prior surgery, intervention, or minimally invasive therapy, (MIST) for the prostate cancer",
                    "criterion": "prior prostate cancer treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Any prior surgery, intervention, or minimally invasive therapy, (MIST) for the ... bladder neck",
                    "criterion": "prior bladder neck treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Treated within the past 5 years for genital cancer",
            "criterions": [
                {
                    "exact_snippets": "Treated within the past 5 years for genital cancer",
                    "criterion": "treatment for genital cancer",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Presence of any urethral or prostatic condition that precludes water vapor ablation per Instructions for Use",
            "criterions": [
                {
                    "exact_snippets": "Presence of any urethral or prostatic condition that precludes water vapor ablation",
                    "criterion": "urethral or prostatic condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "impact on treatment",
                            "expected_value": "precludes water vapor ablation"
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Currently taking medications that have hormonal effects on the prostate or PSA, such as: 5 alpha reductase inhibitors (if on for <6 months, 6-month washout), Androgen blockers, Luteinizing hormone-releasing hormone (LHRH) agonists or antagonists (12-month washout), or Testosterone supplementation (3-month washout)",
            "criterions": [
                {
                    "exact_snippets": "Currently taking medications that have hormonal effects on the prostate or PSA",
                    "criterion": "medications with hormonal effects on prostate or PSA",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "5 alpha reductase inhibitors (if on for <6 months, 6-month washout)",
                    "criterion": "5 alpha reductase inhibitors",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<",
                                "value": 6,
                                "unit": "months"
                            }
                        },
                        {
                            "requirement_type": "washout period",
                            "expected_value": {
                                "operator": "=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Androgen blockers",
                    "criterion": "Androgen blockers",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Luteinizing hormone-releasing hormone (LHRH) agonists or antagonists (12-month washout)",
                    "criterion": "Luteinizing hormone-releasing hormone (LHRH) agonists or antagonists",
                    "requirements": [
                        {
                            "requirement_type": "washout period",
                            "expected_value": {
                                "operator": "=",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Testosterone supplementation (3-month washout)",
                    "criterion": "Testosterone supplementation",
                    "requirements": [
                        {
                            "requirement_type": "washout period",
                            "expected_value": {
                                "operator": "=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Active urinary tract infection. Subjects with an active infection who can be treated and re-tested with a negative result within the screening window are acceptable.",
            "criterions": [
                {
                    "exact_snippets": "Active urinary tract infection",
                    "criterion": "urinary tract infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Subjects with an active infection who can be treated and re-tested with a negative result within the screening window are acceptable",
                    "criterion": "urinary tract infection",
                    "requirements": [
                        {
                            "requirement_type": "treatability",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "re-test result",
                            "expected_value": "negative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Active or clinically chronic prostatitis or granulomatous prostatitis",
            "criterions": [
                {
                    "exact_snippets": "Active or clinically chronic prostatitis",
                    "criterion": "prostatitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "active",
                                "clinically chronic"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "granulomatous prostatitis",
                    "criterion": "granulomatous prostatitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "13. Treated within the past 5 years for a lower and/or upper urinary tract malignancy.",
            "criterions": [
                {
                    "exact_snippets": "Treated within the past 5 years",
                    "criterion": "treatment for urinary tract malignancy",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "lower and/or upper urinary tract malignancy",
                    "criterion": "urinary tract malignancy",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": [
                                "lower",
                                "upper"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "14. Any previous treatment for prostate cancer.",
            "criterions": [
                {
                    "exact_snippets": "Any previous treatment for prostate cancer.",
                    "criterion": "previous treatment for prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "16. Unable to stop taking antiplatelet medications or other blood thinning agents",
            "criterions": [
                {
                    "exact_snippets": "Unable to stop taking antiplatelet medications",
                    "criterion": "antiplatelet medications",
                    "requirements": [
                        {
                            "requirement_type": "ability to stop",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Unable to stop taking ... other blood thinning agents",
                    "criterion": "blood thinning agents",
                    "requirements": [
                        {
                            "requirement_type": "ability to stop",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "17. Known allergy to nickel",
            "criterions": [
                {
                    "exact_snippets": "Known allergy to nickel",
                    "criterion": "allergy to nickel",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "18. Allergic to medication required by the study such as MRI contrast or anesthesia",
            "criterions": [
                {
                    "exact_snippets": "Allergic to medication required by the study such as MRI contrast",
                    "criterion": "allergy to MRI contrast",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Allergic to medication required by the study such as ... anesthesia",
                    "criterion": "allergy to anesthesia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "19. Any significant medical history that would pose an unreasonable risk or make the subject unsuitable for the study",
            "criterions": [
                {
                    "exact_snippets": "significant medical history",
                    "criterion": "medical history",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        }
                    ]
                },
                {
                    "exact_snippets": "pose an unreasonable risk",
                    "criterion": "risk",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "unreasonable"
                        }
                    ]
                },
                {
                    "exact_snippets": "make the subject unsuitable for the study",
                    "criterion": "suitability for the study",
                    "requirements": [
                        {
                            "requirement_type": "suitability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "20. Any cognitive or psychiatric condition that interferes with or precludes direct and accurate communication with the study Investigator regarding the study or affects the ability to complete the study quality of life questionnaires",
            "criterions": [
                {
                    "exact_snippets": "Any cognitive or psychiatric condition that interferes with or precludes direct and accurate communication with the study Investigator",
                    "criterion": "cognitive or psychiatric condition",
                    "requirements": [
                        {
                            "requirement_type": "interference with communication",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Any cognitive or psychiatric condition that ... affects the ability to complete the study quality of life questionnaires",
                    "criterion": "cognitive or psychiatric condition",
                    "requirements": [
                        {
                            "requirement_type": "affects ability to complete questionnaires",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "21. Subject currently participating in other premarket investigational studies unless approved by Sponsor in writing",
            "criterions": [
                {
                    "exact_snippets": "Subject currently participating in other premarket investigational studies",
                    "criterion": "participation in other premarket investigational studies",
                    "requirements": [
                        {
                            "requirement_type": "participation",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "22. Subject is considered vulnerable such as incarcerated or cognitively impaired.",
            "criterions": [
                {
                    "exact_snippets": "Subject is considered vulnerable such as incarcerated",
                    "criterion": "vulnerability",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "incarcerated"
                        }
                    ]
                },
                {
                    "exact_snippets": "Subject is considered vulnerable such as ... cognitively impaired",
                    "criterion": "vulnerability",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "cognitively impaired"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "15. Any rectal pathology, anomaly or previous treatment that could change properties of rectal wall or insertion and use of TRUS",
            "criterions": [
                {
                    "exact_snippets": "Any rectal pathology",
                    "criterion": "rectal pathology",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "any ... anomaly",
                    "criterion": "rectal anomaly",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "previous treatment that could change properties of rectal wall",
                    "criterion": "previous treatment affecting rectal wall",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "previous treatment that could change properties of ... insertion and use of TRUS",
                    "criterion": "previous treatment affecting TRUS use",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}