{
    "info": {
        "nct_id": "NCT01566682",
        "official_title": "A Multi-Center Trial of the ProLung Test™ (Transthoracic Bioconductance Measurement) as an Adjunct to CT Chest Scans for the Risk Stratification of Patients With Pulmonary Lesions Suspicious for Lung Cancer",
        "inclusion_criteria": "Subjects who meet all of the following criteria may be enrolled in this Study:\n\n1. Subject is male or female, age 18 or older.\n2. Subject has undergone CT scan of the lung(s) that indicates one or more nodules or lesions suspicious for lung cancer.\n3. Subject's pulmonary nodule or lesion is greater than 4mm. Size is determined by the largest nodule or lesion dimension identified from CT imaging.\n4. Subject meets one or more of the following conditions:\n\n   * indicated for a tissue biopsy\n   * indicated for surgical resection of the lung\n5. Subject must be able to receive a ProLung Test\n\n   * within 60 days of abnormal CT (Inclusion Criterion 2 & 3)\n   * within 60 days prior to the tissue biopsy or surgical resection (Inclusion Criterion 4).\n6. Subject is capable of understanding and agreeing to fulfill the requirements of this Protocol.\n7. Subject has signed the IRB/IEC approved Informed Consent Form (\"ICF\").\n\nExclusion Criteria\n\nThe following criteria will disqualify a subject from enrollment into this Study:\n\n1. Subject has an implanted electronic device in the chest.\n2. Subject receiving therapy for suspected chest infection such as fungal infection or tuberculosis.\n3. Subject with diagnosed malignancy other than lung cancer, non-melanoma skin cancer or any cancer in which the Principal Investigator does not suspect metastatic disease to the lung, who has 2 or more suspicious pulmonary nodules.\n4. Subject has received an invasive medical or surgical procedure within the thoracic cavity within 30 days prior to the ProLung Test or within the previous 14 days for a bronchoscopic procedure.\n5. Subject presents with an anomalous physical or anatomical condition that precludes ProLung Test measurement.\n6. Subject will have undergone unusually strenuous exercise within 24 hours.\n7. Subject who has significant systemic diseases such as uncontrolled diabetes, advanced heart failure, or a recent myocardial infarction, or other medical condition such as severe morbid obesity that in the judgment of the Principal Investigator would make him/her unsuitable for the Study.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Subject is male or female, age 18 or older.",
            "criterions": [
                {
                    "exact_snippets": "Subject is male or female",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "age 18 or older",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Subject has undergone CT scan of the lung(s) that indicates one or more nodules or lesions suspicious for lung cancer.",
            "criterions": [
                {
                    "exact_snippets": "undergone CT scan of the lung(s)",
                    "criterion": "CT scan of the lung(s)",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "one or more nodules or lesions suspicious for lung cancer",
                    "criterion": "nodules or lesions suspicious for lung cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Subject's pulmonary nodule or lesion is greater than 4mm. Size is determined by the largest nodule or lesion dimension identified from CT imaging.",
            "criterions": [
                {
                    "exact_snippets": "Subject's pulmonary nodule or lesion is greater than 4mm",
                    "criterion": "pulmonary nodule or lesion size",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">",
                                "value": 4,
                                "unit": "mm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Size is determined by the largest nodule or lesion dimension identified from CT imaging",
                    "criterion": "method of size determination",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": "CT imaging"
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Subject meets one or more of the following conditions:",
            "criterions": [
                {
                    "exact_snippets": "Subject meets one or more of the following conditions",
                    "criterion": "conditions",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* indicated for a tissue biopsy",
            "criterions": [
                {
                    "exact_snippets": "indicated for a tissue biopsy",
                    "criterion": "tissue biopsy",
                    "requirements": [
                        {
                            "requirement_type": "indication",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* indicated for surgical resection of the lung",
            "criterions": [
                {
                    "exact_snippets": "indicated for surgical resection of the lung",
                    "criterion": "surgical resection indication",
                    "requirements": [
                        {
                            "requirement_type": "body part",
                            "expected_value": "lung"
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Subject must be able to receive a ProLung Test",
            "criterions": [
                {
                    "exact_snippets": "Subject must be able to receive a ProLung Test",
                    "criterion": "ProLung Test",
                    "requirements": [
                        {
                            "requirement_type": "ability to receive",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* within 60 days of abnormal CT (Inclusion Criterion 2 & 3)",
            "criterions": [
                {
                    "exact_snippets": "within 60 days of abnormal CT",
                    "criterion": "time since abnormal CT",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 60,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* within 60 days prior to the tissue biopsy or surgical resection (Inclusion Criterion 4).",
            "criterions": [
                {
                    "exact_snippets": "within 60 days prior to the tissue biopsy or surgical resection",
                    "criterion": "time frame before procedure",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 60,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Subject is capable of understanding and agreeing to fulfill the requirements of this Protocol.",
            "criterions": [
                {
                    "exact_snippets": "Subject is capable of understanding",
                    "criterion": "understanding capability",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "agreeing to fulfill the requirements of this Protocol",
                    "criterion": "agreement to fulfill protocol requirements",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Subject has signed the IRB/IEC approved Informed Consent Form (\"ICF\").",
            "criterions": [
                {
                    "exact_snippets": "Subject has signed the IRB/IEC approved Informed Consent Form (\"ICF\").",
                    "criterion": "informed consent form",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "approval",
                            "expected_value": "IRB/IEC"
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. Subject has an implanted electronic device in the chest.",
            "criterions": [
                {
                    "exact_snippets": "implanted electronic device in the chest",
                    "criterion": "implanted electronic device",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "chest"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Subject receiving therapy for suspected chest infection such as fungal infection or tuberculosis.",
            "criterions": [
                {
                    "exact_snippets": "therapy for suspected chest infection",
                    "criterion": "therapy for chest infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "such as fungal infection",
                    "criterion": "fungal infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "tuberculosis",
                    "criterion": "tuberculosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Subject with diagnosed malignancy other than lung cancer, non-melanoma skin cancer or any cancer in which the Principal Investigator does not suspect metastatic disease to the lung, who has 2 or more suspicious pulmonary nodules.",
            "criterions": [
                {
                    "exact_snippets": "diagnosed malignancy other than lung cancer, non-melanoma skin cancer",
                    "criterion": "diagnosed malignancy",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "other than lung cancer",
                                "non-melanoma skin cancer"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "any cancer in which the Principal Investigator does not suspect metastatic disease to the lung",
                    "criterion": "metastatic disease to the lung",
                    "requirements": [
                        {
                            "requirement_type": "suspicion",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "2 or more suspicious pulmonary nodules",
                    "criterion": "suspicious pulmonary nodules",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "nodules"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Subject has received an invasive medical or surgical procedure within the thoracic cavity within 30 days prior to the ProLung Test or within the previous 14 days for a bronchoscopic procedure.",
            "criterions": [
                {
                    "exact_snippets": "Subject has received an invasive medical or surgical procedure within the thoracic cavity within 30 days prior to the ProLung Test",
                    "criterion": "invasive medical or surgical procedure within the thoracic cavity",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Subject has received ... within the previous 14 days for a bronchoscopic procedure",
                    "criterion": "bronchoscopic procedure",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Subject presents with an anomalous physical or anatomical condition that precludes ProLung Test measurement.",
            "criterions": [
                {
                    "exact_snippets": "anomalous physical or anatomical condition",
                    "criterion": "physical or anatomical condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "anomalous"
                        }
                    ]
                },
                {
                    "exact_snippets": "precludes ProLung Test measurement",
                    "criterion": "ProLung Test measurement",
                    "requirements": [
                        {
                            "requirement_type": "feasibility",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Subject will have undergone unusually strenuous exercise within 24 hours.",
            "criterions": [
                {
                    "exact_snippets": "undergone unusually strenuous exercise within 24 hours",
                    "criterion": "strenuous exercise",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 24 hours"
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Subject who has significant systemic diseases such as uncontrolled diabetes, advanced heart failure, or a recent myocardial infarction, or other medical condition such as severe morbid obesity that in the judgment of the Principal Investigator would make him/her unsuitable for the Study.",
            "criterions": [
                {
                    "exact_snippets": "significant systemic diseases such as uncontrolled diabetes",
                    "criterion": "systemic diseases",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        },
                        {
                            "requirement_type": "examples",
                            "expected_value": [
                                "uncontrolled diabetes"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "advanced heart failure",
                    "criterion": "heart failure",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "advanced"
                        }
                    ]
                },
                {
                    "exact_snippets": "recent myocardial infarction",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "recency",
                            "expected_value": "recent"
                        }
                    ]
                },
                {
                    "exact_snippets": "severe morbid obesity",
                    "criterion": "morbid obesity",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                }
            ]
        },
        {
            "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": [],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "Subjects who meet all of the following criteria may be enrolled in this Study:",
            "criterions": []
        },
        {
            "line": "Exclusion Criteria",
            "criterions": []
        },
        {
            "line": "The following criteria will disqualify a subject from enrollment into this Study:",
            "criterions": []
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}