Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-26 @ 4:07 AM
Study NCT ID:
NCT05990218
Status:
RECRUITING
Last Update Posted:
2024-12-13
First Post:
2023-08-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Artificial Intelligence in the Detection of Right Sided Colonic Polyp in Different Operator Experience
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003111', 'term': 'Colonic Polyps'}], 'ancestors': [{'id': 'D007417', 'term': 'Intestinal Polyps'}, {'id': 'D011127', 'term': 'Polyps'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'The patients were masked from being randomized to operator and endoscopic method'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients randomized to 4 arms: control with experienced operator, control with beginner operator, AI with experienced operator, AI with beginner operator'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 240}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2026-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-09', 'studyFirstSubmitDate': '2023-08-06', 'studyFirstSubmitQcDate': '2023-08-06', 'lastUpdatePostDateStruct': {'date': '2024-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'polyp detection rate', 'timeFrame': 'during endoscopy', 'description': 'the number of polyp detected during endoscopy'}], 'secondaryOutcomes': [{'measure': 'type of polyp', 'timeFrame': 'during endoscopy', 'description': 'the type of polyp detected during endoscopy'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['colon polyp', 'artificial intellegence', 'colonoscopy'], 'conditions': ['Colon Polyp']}, 'referencesModule': {'references': [{'pmid': '34218329', 'type': 'BACKGROUND', 'citation': 'Kamba S, Tamai N, Saitoh I, Matsui H, Horiuchi H, Kobayashi M, Sakamoto T, Ego M, Fukuda A, Tonouchi A, Shimahara Y, Nishikawa M, Nishino H, Saito Y, Sumiyama K. Reducing adenoma miss rate of colonoscopy assisted by artificial intelligence: a multicenter randomized controlled trial. J Gastroenterol. 2021 Aug;56(8):746-757. doi: 10.1007/s00535-021-01808-w. Epub 2021 Jul 3.'}]}, 'descriptionModule': {'briefSummary': 'Colonoscopy is the gold standard modality for the detection of colonic polyp. However, miss polyp occurs especially in right sided colon. Artificial intelligence (AI) is one of the modality to improve polyp detection but the benefit of AI in operators with different endoscopic experience is still limited. This study aimed to evaluate the efficacy of AI in the detection of right sided colonic polyp in operators with different endoscopic experience by using double insertion of right side colon, back-to-back basis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* participants age 40-80 years\n\nExclusion Criteria:\n\n* History of colonic surgery (except appendectomy)\n* Lower gastrointestinal bleeding\n* unstable vital sign during endoscopy of pregnancy\n* history of inflammatory bowel disease, polyposis syndrome, colon cancer, colonic stricture, abnormal coaglulation, organ failure'}, 'identificationModule': {'nctId': 'NCT05990218', 'briefTitle': 'Artificial Intelligence in the Detection of Right Sided Colonic Polyp in Different Operator Experience', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Department of Medical Services Ministry of Public Health of Thailand'}, 'officialTitle': 'Efficacy of Artificial Intelligence in the Detection of Right Sided Colonic Polyp in Operators with Different Endoscopic Experience: a Randomized Control Trial', 'orgStudyIdInfo': {'id': '031/2566'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'control, experienced', 'description': 'Patients received colonoscopy with double insertion of right sided colon under white light by experienced endoscopist', 'interventionNames': ['Device: control']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'control, beginner', 'description': 'Patients received colonoscopy with double insertion of right sided colon under white light by beginner endoscopist', 'interventionNames': ['Device: control']}, {'type': 'EXPERIMENTAL', 'label': 'AI, experience', 'description': 'Patients received colonoscopy with double insertion of right sided colon under AI by experienced endoscopist', 'interventionNames': ['Device: Artificial intellegence. CADe syste,']}, {'type': 'EXPERIMENTAL', 'label': 'AI, beginner', 'description': 'Patients received colonoscopy with double insertion of right sided colon under AI by beginner endoscopist', 'interventionNames': ['Device: Artificial intellegence. CADe syste,']}], 'interventions': [{'name': 'Artificial intellegence. CADe syste,', 'type': 'DEVICE', 'description': 'The patient received endoscopy under CADe system for polyp detection during second endoscopic withdrawal.', 'armGroupLabels': ['AI, beginner', 'AI, experience']}, {'name': 'control', 'type': 'DEVICE', 'description': 'The patient received endoscopy under conventional white light for polyp detection during second endoscopic withdrawal.', 'armGroupLabels': ['control, beginner', 'control, experienced']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bangkok', 'state': 'Bangkok', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Tanyaporn Chantarojanasiri, MD', 'role': 'CONTACT', 'email': 'chtunya@gmail.com', 'phone': '0898104033'}, {'name': 'Tanyaporn Chantarojanasiri, MD', 'role': 'CONTACT'}], 'facility': 'Rajavithi Hospital', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Department of Medical Services Ministry of Public Health of Thailand', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}