Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-28 @ 11:39 PM
Study NCT ID:
NCT05718193
Status:
COMPLETED
Last Update Posted:
2023-04-11
First Post:
2023-01-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Real-Time Artificial Intelligence Assissted Colonoscopy to Identify and Classify Polyps
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2868}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2023-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-09', 'studyFirstSubmitDate': '2023-01-03', 'studyFirstSubmitQcDate': '2023-01-29', 'lastUpdatePostDateStruct': {'date': '2023-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'adenoma detection rate', 'timeFrame': 'up to 9 months', 'description': 'Percentage of patients who have 1 or more histologically confirmed adenoma resected divided by the total number of colonoscopies.'}, {'measure': 'adenomas per colonoscopy', 'timeFrame': 'up to 9 months', 'description': 'Total number of histologically confirmed adenomas resected divided by the total number of colonoscopies.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Artificial Intelligence', 'Colonoscopy', 'Quality Control']}, 'descriptionModule': {'briefSummary': 'To investigate the degree of the real-time detection and classification system for increasing the adenoma detection rate during colonoscopy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAged 18 to 85 years old. Colonoscopies for primary CRC screening of the subjects are required.\n\nExclusion Criteria:\n\nHistory of CRC,inflammatory bowel disease, previous colonic resection, antithrombotic therapy precluding polyp resection.'}, 'identificationModule': {'nctId': 'NCT05718193', 'briefTitle': 'Real-Time Artificial Intelligence Assissted Colonoscopy to Identify and Classify Polyps', 'organization': {'class': 'OTHER', 'fullName': 'Xiangya Hospital of Central South University'}, 'officialTitle': 'Real-Time Artificial Intelligence Assissted Colonoscopy to Identify and Classify Polyps', 'orgStudyIdInfo': {'id': '202112254'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'The DeFrame Group', 'description': 'Subjects in the DeFrame group were treated with a real-time computer-aided polyp detection system named DeFrame during colonoscopy.', 'interventionNames': ['Diagnostic Test: DeFrame']}, {'type': 'EXPERIMENTAL', 'label': 'The Classified DeFrame Group', 'description': 'Subjects in the Classified DeFrame group were treated with a real-time computer-aided polyp detection and classification system named Classified DeFrame during colonoscopy.', 'interventionNames': ['Diagnostic Test: Classified DeFrame']}, {'type': 'EXPERIMENTAL', 'label': 'The Control Group', 'description': 'Subjects in the control group underwent standard colonoscopy.', 'interventionNames': ['Diagnostic Test: conventional colonoscopy']}], 'interventions': [{'name': 'DeFrame', 'type': 'DIAGNOSTIC_TEST', 'description': 'The DeFrame system is applicated during colonoscopy. The DeFrame system superimposes a rectangular box on the polyp lesion area in the colonoscopy field of view, notifying the endoscopists of the presence of the lesion.', 'armGroupLabels': ['The DeFrame Group']}, {'name': 'Classified DeFrame', 'type': 'DIAGNOSTIC_TEST', 'description': 'The Classified DeFrame system is applicated during colonoscopy. The Classified DeFrame system superimposes a rectangular box on the polyp lesion area in the colonoscopy field of view, the color of the rectangle box will turn blue when the polyp is considered as an adenoma, notifying the endoscopists of the presence of the lesion.', 'armGroupLabels': ['The Classified DeFrame Group']}, {'name': 'conventional colonoscopy', 'type': 'DIAGNOSTIC_TEST', 'description': 'conventional colonoscopy', 'armGroupLabels': ['The Control Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Changsha', 'state': 'Hunan', 'country': 'China', 'facility': 'Xiangya Hospital Central South University', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'city': 'Loudi', 'state': 'Hunan', 'country': 'China', 'facility': 'Loudi Central Hospital', 'geoPoint': {'lat': 27.73444, 'lon': 111.99444}}], 'overallOfficials': [{'name': 'xiaowei liu, doctor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Xiangya Hospital of Central South University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xiangya Hospital of Central South University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Loudi Central Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}