{
    "info": {
        "nct_id": "NCT06679920",
        "official_title": "IDEAL Phase II Study of a Newly Designed Optical Coherence Tomography Probe During Transurethral Resection for Optimizing Bladder Cancer Diagnosis and Treatment",
        "inclusion_criteria": "* Age > 18 years.\n* Have at least 1 suspected bladder tumour seen at cystoscopy.\n* Have a bladder that is accessible for cystoscopy.\n* Be in a physical condition to undergo a TURBT.\n* Eligible patients must be fully informed about the study and written signed informed consent must be obtained prior to any study related investigation/intervention.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Pregnant or lactating women.\n* The only tumour site is at the bladder neck.\n* The tumour(s) is larger than 2 centimetres in diameter.\n* >5 tumours present.\n* Solely a suspected flat lesion present.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Age > 18 years.",
            "criterions": [
                {
                    "exact_snippets": "Age > 18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have at least 1 suspected bladder tumour seen at cystoscopy.",
            "criterions": [
                {
                    "exact_snippets": "at least 1 suspected bladder tumour seen at cystoscopy",
                    "criterion": "bladder tumour",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        },
                        {
                            "requirement_type": "detection method",
                            "expected_value": "cystoscopy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have a bladder that is accessible for cystoscopy.",
            "criterions": [
                {
                    "exact_snippets": "bladder that is accessible for cystoscopy",
                    "criterion": "bladder accessibility",
                    "requirements": [
                        {
                            "requirement_type": "accessibility",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Be in a physical condition to undergo a TURBT.",
            "criterions": [
                {
                    "exact_snippets": "Be in a physical condition to undergo a TURBT.",
                    "criterion": "physical condition",
                    "requirements": [
                        {
                            "requirement_type": "suitability for procedure",
                            "expected_value": "TURBT"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Eligible patients must be fully informed about the study and written signed informed consent must be obtained prior to any study related investigation/intervention.",
            "criterions": [
                {
                    "exact_snippets": "Eligible patients must be fully informed about the study",
                    "criterion": "patient information",
                    "requirements": [
                        {
                            "requirement_type": "informed",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "written signed informed consent must be obtained",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Pregnant or lactating women.",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "lactating women",
                    "criterion": "lactation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The only tumour site is at the bladder neck.",
            "criterions": [
                {
                    "exact_snippets": "tumour site is at the bladder neck",
                    "criterion": "tumour site",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "bladder neck"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The tumour(s) is larger than 2 centimetres in diameter.",
            "criterions": [
                {
                    "exact_snippets": "tumour(s) is larger than 2 centimetres in diameter",
                    "criterion": "tumour size",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "centimetres"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* >5 tumours present.",
            "criterions": [
                {
                    "exact_snippets": ">5 tumours present",
                    "criterion": "tumours",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 5,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Solely a suspected flat lesion present.",
            "criterions": [
                {
                    "exact_snippets": "suspected flat lesion",
                    "criterion": "flat lesion",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "certainty",
                            "expected_value": "suspected"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}