Ignite Creation Date:
2025-12-24 @ 9:37 PM
Ignite Modification Date:
2026-01-02 @ 3:55 AM
Study NCT ID:
NCT05614232
Status:
COMPLETED
Last Update Posted:
2022-11-14
First Post:
2022-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate the Effectiveness of the Device in Detection of Abnormal Findings on Chest X-ray
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008171', 'term': 'Lung Diseases'}], 'ancestors': [{'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014965', 'term': 'X-Rays'}], 'ancestors': [{'id': 'D060733', 'term': 'Electromagnetic Radiation'}, {'id': 'D055590', 'term': 'Electromagnetic Phenomena'}, {'id': 'D060328', 'term': 'Magnetic Phenomena'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D011839', 'term': 'Radiation, Ionizing'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 700}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-09', 'studyFirstSubmitDate': '2022-11-02', 'studyFirstSubmitQcDate': '2022-11-09', 'lastUpdatePostDateStruct': {'date': '2022-11-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the effectiveness of the investigational device', 'timeFrame': 'through study completion, an average of 6 months', 'description': 'Area Under the Receiver Operating Characteristic Curve (ROC AUC) of the investigational device in detection of overall target radiologic findings (detection of any abnormal findings among ten target radiologic findings)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pulmonary Disease']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the effectiveness of the investigational device (Lunit INSIGHT CXR) in the detection of chest abnormalities', 'detailedDescription': 'In the study, the standalone performance of Lunit INSIGHT CXR was primarily assessed by comparing the analysis results from the investigational device and reference standards in the detection of 10 abnormal radiologic findings - atelectasis, calcification, cardiomegaly, consolidation, fibrosis, mediastinal widening, nodule/mass, pleural effusion, pneumoperitoneum, and pneumothorax.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '14 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Secondary hospital patient', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chest radiographs of aged 14 years or older\n* Conventional PA or AP chest radiographs\n* Chest radiographs with confirmed radiology reports\n\nExclusion Criteria:\n\n* Chest radiographs taken in postures other than PA and AP\n* Chest radiographs from dual-energy radiography\n* Invert-grayscale chest radiographs'}, 'identificationModule': {'nctId': 'NCT05614232', 'briefTitle': 'Study to Evaluate the Effectiveness of the Device in Detection of Abnormal Findings on Chest X-ray', 'organization': {'class': 'INDUSTRY', 'fullName': 'Lunit Inc.'}, 'officialTitle': 'Single-Center, Retrospective, Pivotal Study to Evaluate the Effectiveness of Investigational Device (Lunit INSIGHT CXR) in Detection of Abnormal Findings on Chest Radiographs', 'orgStudyIdInfo': {'id': 'LUN_CXR_CA_221'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Positive group', 'description': 'chest radiographs with the specific target radiologic findings (Atelectasis, Calcification, Cardiomegaly, Consolidation, Fibrosis, Mediastinal Widening, Nodule/Mass, Pleural Effusion, Pneumoperitoneum, Pneumothorax)', 'interventionNames': ['Radiation: Chest X-ray']}, {'label': 'Negative group', 'description': 'chest radiographs with no target radiologic findings', 'interventionNames': ['Radiation: Chest X-ray']}], 'interventions': [{'name': 'Chest X-ray', 'type': 'RADIATION', 'description': 'Chest radiographs', 'armGroupLabels': ['Negative group', 'Positive group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07061', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'SMG-SNU Boramae Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lunit Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}