Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2026-02-25 @ 5:50 PM
Study NCT ID:
NCT05317351
Status:
UNKNOWN
Last Update Posted:
2022-04-07
First Post:
2022-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Prospective Randomized Study Comparing the Adenoma Detection Yield of SC, AI and Combined AI and G-EYE®
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003110', 'term': 'Colonic Neoplasms'}, {'id': 'D000236', 'term': 'Adenoma'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a multicenter, 3-arm, randomized, open-label study. Subjects referred to colonoscopy for screening or surveillance will be randomized in a 2:5:5 into one of the following arms: (i) Standard Colonoscopy, (ii) Artificial Intelligence Aided Colonoscopy (GI Genius™), and (iii) Combined Artificial Intelligence Aided Colonoscopy (GI Genius™) and G-EYE® Balloon Aided Colonoscopy'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2160}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-31', 'studyFirstSubmitDate': '2022-03-31', 'studyFirstSubmitQcDate': '2022-03-31', 'lastUpdatePostDateStruct': {'date': '2022-04-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adenoma Per Colonoscopy (APC) (AI compared with AG)', 'timeFrame': 'Upon histology results (up to 30 days)', 'description': 'Adenoma detection yield, represented by Adenoma Per Colonoscopy (APC) of AI compared with APC of AG.'}], 'secondaryOutcomes': [{'measure': 'Adenoma Per Colonoscopy (APC) (SC compared with AG)', 'timeFrame': 'Upon histology results (up to 30 days)', 'description': 'Adenoma detection yield, represented by Adenoma Per Colonoscopy (APC) of SC compared with APC of AG'}, {'measure': 'Advanced Adenoma Per Colonoscopy (AAPC) (SC compared with AG)', 'timeFrame': 'Upon histology results (up to 30 days)', 'description': 'Advanced Adenoma detection yield, represented by Advanced Adenoma Per Colonoscopy (AAPC) of SC compared with AAPC of AG'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Colorectal (Colon or Rectal) Cancer', 'Adenoma']}, 'descriptionModule': {'briefSummary': 'This is a multicenter, 3-arm, randomized, open-label study. Subjects referred to colonoscopy for screening or surveillance will be randomized in a 2:5:5 into one of the following arms:\n\n(i) Standard Colonoscopy (ii) Artificial Intelligence Aided Colonoscopy (GI Genius™) (iii) Combined Artificial Intelligence Aided Colonoscopy (GI Genius™) and G-EYE® Balloon Aided Colonoscopy', 'detailedDescription': 'This is a multicenter, 3-arm, randomized, open-label study. Subjects referred to colonoscopy for screening or surveillance will be randomized in a 2:5:5 into one of the following arms:\n\n(i) Standard Colonoscopy (ii) Artificial Intelligence Aided Colonoscopy (GI Genius™) (iii) Combined Artificial Intelligence Aided Colonoscopy (GI Genius™) and G-EYE® Balloon Aided Colonoscopy Study aim is to compare the adenoma detection yield, expressed by Adenoma Per Colonoscopy (APC), of these 3 arms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients of age ≥ 45 years old\n2. Referred to colonoscopy for screening or surveillance colonoscopy (history of adenoma resection)\n3. The patient must understand and provide written consent for the procedure.\n\nExclusion Criteria:\n\n1. Subjects with inflammatory bowel disease\n2. Subjects with a personal history of polyposis syndrome\n3. Subjects with suspected chronic stricture potentially precluding complete colonoscopy\n4. Subjects with diverticulitis or toxic megacolon\n5. Subjects with a history of radiation therapy to abdomen or pelvis\n6. Pregnant or lactating female subjects\n7. Subjects who are currently enrolled in another clinical investigation.\n8. Subjects with current oral or parenteral use of anticoagulants, not considered eligible by the investigator.\n9. Subjects with recent (within the last 3 mounts) coronary ischemia or CVA (stroke)\n10. Any patient condition deemed too risky for the study by the investigator\n11. Previous colonic surgery (except for appendectomy)'}, 'identificationModule': {'nctId': 'NCT05317351', 'briefTitle': 'A Prospective Randomized Study Comparing the Adenoma Detection Yield of SC, AI and Combined AI and G-EYE®', 'organization': {'class': 'INDUSTRY', 'fullName': 'Smart Medical Systems Ltd.'}, 'officialTitle': 'A Prospective Randomized Study Comparing the Adenoma Detection Yield of (i) Standard Colonoscopy ("SC"), (ii) Artificial Intelligence (GI Genius™) ("AI"), and (Iii) Combined Artificial Intelligence (GI Genius™) and G-EYE® Colonoscopy', 'orgStudyIdInfo': {'id': 'G-EYE15080'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Colonoscopy ("SC")', 'description': 'Subjects enrolled to arm 1 ("SC") will undergo colonoscopy using a standard colonoscope.', 'interventionNames': ['Device: Standard Colonoscopy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Artificial Intelligence Aided Colonoscopy (GI Genius™) ("AI")', 'description': 'Subjects enrolled to arm 2 ("AI") will undergo colonoscopy using a standard colonoscope aided by Artificial Intelligence (GI Genius™)', 'interventionNames': ['Device: Artificial Intelligence Aided Colonoscopy (GI Genius™)']}, {'type': 'EXPERIMENTAL', 'label': 'Combined Artificial Intelligence (GI Genius™) and G-EYE® Colonoscopy (AG)', 'description': 'Subjects enrolled to arm 3 ("AG") will undergo colonoscopy using the G-EYE® Colonoscope and Artificial Intelligence Aided Colonoscopy (GI Genius™).', 'interventionNames': ['Device: Combined Artificial Intelligence Aided Colonoscopy (GI Genius™) and G-EYE® Balloon Aided Colonoscopy']}], 'interventions': [{'name': 'Standard Colonoscopy', 'type': 'DEVICE', 'description': 'Subjects randomized into arm 1 will undergo standard colonoscopy using a standard colonoscope', 'armGroupLabels': ['Standard Colonoscopy ("SC")']}, {'name': 'Artificial Intelligence Aided Colonoscopy (GI Genius™)', 'type': 'DEVICE', 'description': 'Subjects randomized into arm 2 will undergo colonoscopy using a standard colonoscope aided by Artificial Intelligence (GI Genius™)', 'armGroupLabels': ['Artificial Intelligence Aided Colonoscopy (GI Genius™) ("AI")']}, {'name': 'Combined Artificial Intelligence Aided Colonoscopy (GI Genius™) and G-EYE® Balloon Aided Colonoscopy', 'type': 'DEVICE', 'description': 'Subjects enrolled to arm 3 ("AG") will undergo colonoscopy using the G-EYE® Colonoscope and Artificial Intelligence Aided Colonoscopy (GI Genius™).', 'armGroupLabels': ['Combined Artificial Intelligence (GI Genius™) and G-EYE® Colonoscopy (AG)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'contacts': [{'name': 'Douglas K Rex, MD', 'role': 'CONTACT', 'email': 'drex@iu.edu', 'phone': '317-777-9676'}], 'facility': 'Indiana University', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'contacts': [{'name': 'Seth A Gross, MD', 'role': 'CONTACT', 'email': 'Seth.Gross@nyulangone.org', 'phone': '212-263-3095'}], 'facility': 'NYU Langone Health', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'centralContacts': [{'name': 'Douglas K Rex, MD', 'role': 'CONTACT', 'email': 'drex@iu.edu', 'phone': '317-777-9676'}], 'overallOfficials': [{'name': 'Douglad K Rex, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indina University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Smart Medical Systems Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}