Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2025-12-25 @ 9:37 PM
Study NCT ID:
NCT04838951
Status:
COMPLETED
Last Update Posted:
2023-02-08
First Post:
2021-03-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Real-time Computer-aided System (ENDO-AID) on Adenoma Detection in Endoscopist-in-training
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Endoscopist wil not be blinded to treatment. Treatment arm allocation will be concealed to patients, data collector and data analysts.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 856}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-06', 'studyFirstSubmitDate': '2021-03-23', 'studyFirstSubmitQcDate': '2021-04-07', 'lastUpdatePostDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ADR', 'timeFrame': 'During the colonoscopy', 'description': 'adenoma detection rate'}], 'secondaryOutcomes': [{'measure': 'ADR for adenomas of different sizes', 'timeFrame': 'During the colonoscopy', 'description': '\\<5mm, 5-10mm, \\>10mm'}, {'measure': 'ADR for adenomas of different colonic segments', 'timeFrame': 'During the colonoscopy', 'description': 'caecum, ascending colon, hepatic flexure, transverse colon, splenic flexure, descending colon, sigmoid colon, rectum'}, {'measure': 'Mean number of adenomas per colonoscopy', 'timeFrame': 'During the colonoscopy', 'description': 'Mean number of adenomas per colonoscopy'}, {'measure': 'Advanced adenoma detection rate', 'timeFrame': 'During the colonoscopy', 'description': 'Advanced adenoma detection rate'}, {'measure': 'Sessile serrate lesion (SSL) detection rate', 'timeFrame': 'During the colonoscopy', 'description': 'Sessile serrate lesion (SSL) detection rate'}, {'measure': 'Polyp detection rate', 'timeFrame': 'During the colonoscopy', 'description': 'Polyp detection rate'}, {'measure': 'Non-neoplastic resection rate', 'timeFrame': 'During the colonoscopy', 'description': 'defined as absence of adenoma or SSL within resected specimen'}, {'measure': 'Missed polyp rate', 'timeFrame': 'During the colonoscopy', 'description': 'defined as a polyp which the junior endoscopist fails to recognize and withdraws the endoscope to next colonic segment, but detected by the supervisor'}, {'measure': 'False positive rate', 'timeFrame': 'During the colonoscopy', 'description': 'defined as computer artifacts due to colonic mucosal wall or bowel content lasting for \\>2 seconds'}, {'measure': 'Cecal intubation time', 'timeFrame': 'During the colonoscopy', 'description': 'Cecal intubation time'}, {'measure': 'Withdrawal time', 'timeFrame': 'During the colonoscopy', 'description': 'excluding interventions'}, {'measure': 'Total procedural time', 'timeFrame': 'During the colonoscopy', 'description': 'Total procedural time'}, {'measure': 'Percentage of change in ADR in relation to the personal experience in colonoscopy', 'timeFrame': 'During the colonoscopy', 'description': 'Percentage of change in ADR in relation to the personal experience in colonoscopy based on number of procedures performed \\<200 vs 200-500'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Screening Colonoscopy']}, 'referencesModule': {'references': [{'pmid': '37918685', 'type': 'DERIVED', 'citation': 'Lau LHS, Ho JCL, Lai JCT, Ho AHY, Wu CWK, Lo VWH, Lai CMS, Scheppach MW, Sia F, Ho KHK, Xiao X, Yip TCF, Lam TYT, Kwok HYH, Chan HCH, Lui RN, Chan TT, Wong MTL, Ho MF, Ko RCW, Hon SF, Chu S, Futaba K, Ng SSM, Yip HC, Tang RSY, Wong VWS, Chan FKL, Chiu PWY; ENDOAID-TRAIN study group. Effect of Real-Time Computer-Aided Polyp Detection System (ENDO-AID) on Adenoma Detection in Endoscopists-in-Training: A Randomized Trial. Clin Gastroenterol Hepatol. 2024 Mar;22(3):630-641.e4. doi: 10.1016/j.cgh.2023.10.019. Epub 2023 Nov 2.'}]}, 'descriptionModule': {'briefSummary': "The investigator's hypothesis is that a CADe system (ENDO-AID) would improve the adenoma detection rate in junior endoscopists.", 'detailedDescription': 'Colorectal cancer (CRC) is the most common and second most lethal cancer in Hong Kong with more than 5,600 new cases and 2,300 deaths annually. Colonoscopy with polypectomy has shown to reduce CRC-related mortality by 53%. However, high polyp miss rates were reported to be up to 26% for adenomas and 9% for advanced adenomas in standard colonoscopies. Risk factors included proximal location, serrate or flat lesions, poor bowel preparation and short withdrawal time (\\<6 minutes). Insufficient trainee experience was also associated with a higher adenoma miss rate. A significant proportion of interval CRC was attributed to the missed lesions during index colonoscopy leading to adverse patient outcomes.\n\nAs a result, various techniques were developed to improve adenoma detection rate (ADR) during colonoscopies. Techniques including water exchange method, second examination of the right colon (retroflexion or second forward view)and cap/cuff-assisted colonoscopies were proven to increase ADR effectively. However, these techniques were operator-dependent requiring certain level of expertise.\n\nRecently, artificial intelligence and computer-aided polyp detection (CADe) systems have developed rapidly around the globe. These systems can provide real-time CADe by flagging the suspected lesions to endoscopists, with the adoption of deep learning or convoluted neural networks. A number of prospective randomized clinical trials reported a significant increase in ADR in CADe group. The number of adenoma detected per colonoscopy was consistently higher among different polyp sizes, location and morphology. The ADR increment was particularly higher for diminutive adenomas smaller than 5mm.\n\nNevertheless, most of the aforementioned studies only involved senior endoscopists for the procedures. Theoretically, the senior endoscopists were more skillful to expose colonic mucosa and more experienced to distinguish the false positive computer signals, leading to an enhanced performance of CADe in real-time colonoscopies. The effect of CADe on inexperienced junior endoscopists performing colonoscopies remains largely unknown.\n\nIn this single-blind randomized study, the investigators aim to evaluate the effect of a new CADe system (ENDO-AID) on adenoma detection and quality improvement in junior endoscopists.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Aged 18 years old or above;\n2. They require elective colonoscopy for colorectal cancer screening, polyp surveillance, or investigation of symptoms such as anemia or gastrointestinal bleeding;\n3. Written informed consent obtained.\n\nExclusion Criteria:\n\n1. Contraindication to colonoscopy (e.g. intestinal obstruction or perforation)\n2. Contraindication or conditions precluding polyp resection (e.g. active gastrointestinal bleeding, significant bleeding tendency, uninterrupted anticoagulation or dual antiplatelets)\n3. Scheduled staged procedure for polypectomy or biopsy\n4. Previous colonic resection\n5. Personal history of colorectal cancer\n6. Personal history of polyposis syndrome\n7. Personal history of inflammatory bowel disease\n8. Advanced comorbid conditions (defined as American Society of Anesthesiologists grade 4 or above)\n9. Pregnancy\n10. Unable to obtain informed consent'}, 'identificationModule': {'nctId': 'NCT04838951', 'acronym': 'ENDOAIDTRAIN', 'briefTitle': 'Effect of Real-time Computer-aided System (ENDO-AID) on Adenoma Detection in Endoscopist-in-training', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'Effect of Real-time Computer-aided System (ENDO-AID) on Adenoma Detection in Endoscopist-in-training: a Single-blind Randomized Study', 'orgStudyIdInfo': {'id': '2021.141'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention arm', 'description': 'CADe system will be used during withdrawal phase of colonoscopy.', 'interventionNames': ['Device: ENDO-AID CADe']}, {'type': 'NO_INTERVENTION', 'label': 'Control arm', 'description': 'Colonoscopy will be performed according to hospital protocol.'}], 'interventions': [{'name': 'ENDO-AID CADe', 'type': 'DEVICE', 'description': 'ENDO-AID CADe will be used during the withdrawal process of the colonoscopy.', 'armGroupLabels': ['Intervention arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shatin', 'state': 'New Territories', 'country': 'Hong Kong', 'facility': 'Prince of Wales Hospital', 'geoPoint': {'lat': 22.38333, 'lon': 114.18333}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is no plan to share individual participant data to other researchers'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident Specialist', 'investigatorFullName': 'Louis Ho Shing Lau', 'investigatorAffiliation': 'Chinese University of Hong Kong'}}}}