Ignite Creation Date:
2025-12-24 @ 1:49 PM
Ignite Modification Date:
2025-12-24 @ 1:49 PM
Study NCT ID:
NCT05822895
Status:
RECRUITING
Last Update Posted:
2023-05-08
First Post:
2023-04-10
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Review of the Impact of a Computer-aided Real-time Polyp Detection System on Adult Colonoscopy
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 764}, 'targetDuration': '1 Month', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-04', 'studyFirstSubmitDate': '2023-04-10', 'studyFirstSubmitQcDate': '2023-04-10', 'lastUpdatePostDateStruct': {'date': '2023-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ADR', 'timeFrame': '2 weeks for Histological results to return', 'description': 'Adenoma detection rate'}], 'secondaryOutcomes': [{'measure': 'ADPC', 'timeFrame': '2 weeks, for histological results to return', 'description': 'Adenoma detection per colonscopy rate'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Colonic polyp', 'colonoscopy', 'artificial intelligence', 'implementation science'], 'conditions': ['Colonic Polyp']}, 'descriptionModule': {'briefSummary': 'Background:\n\nRemoval of adenomatous polyps during colonoscopy is associated with long-term prevention of colorectal cancer-related deaths. Recently, there have been much interest in the use of artificial intelligence (AI) platforms to augment the routine endoscopic assessment of the colon to enhance adenoma detection rate (ADR). To date, computer assisted detection of polyps (CADe) have been shown to be safe, with a significant increase in ADR, without any concomitant increase in post-procedural complications.\n\nAims:\n\nThe investigators aim to evaluate the use of GI GeniusTM Intelligent Endoscopy Module in a multi-ethnic Asian population (Singapore) to increase in ADR and adenoma detected per colonoscopy (ADPC)to justify its effectiveness as an adjunct in polyp detection and training for colonoscopy.\n\nMethods:\n\nThis study will be a single-institution cohort study, conducted over a 2-year period. Sengkang General Hospital (SKH) does an estimated 12,500 colonoscopies per year, with an average of 1,040 colonoscopies performed every month. Thus, given the case volume, the investigators expect to detect differences in ADR amongst endoscopists if any during this study period.\n\nAs part of the subgroup analysis, the investigators also aim to compare the ADR rates of trainee endoscopists with and without the GI GeniusTM Intelligent Endoscopy Module to ascertain its utility as an education tool/training adjunct', 'detailedDescription': "This study will be a single-institution cohort study, conducted over a 2-year period. The investigators will recruit patients prospectively who would have their colonoscopy performed with AI guidance from the GI Genius, which is a standard of care feature in the endoscopy rooms fitted with the GI Genius, and compare it against historical data when the AI technology was not available (Jan 2018-Jan 2021). This historical data has already been collected as part of a published audit performed for SKH's endoscopy. The data collected for this historical cohort are from an anonymised database collected from Operating Theatre Management Unit (OTMU) (who is not involved in the study).\n\nFor the prospective cohort undergoing AI aided endoscopy (1/4/2023 - 31/3/2025):\n\nThis will include all adult patients going for colonoscopy in the our institution. Patients with incomplete or failed colonoscopy, flexible sigmoidoscopy, colonoscopy done after previous colorectal cancers or previous colonic resections, patients with poor bowel preparation, when deemed by the endoscopist to have an incomplete assessment of the colon, will be excluded from the analysis.\n\npatient demographical data, procedural related data as well as histology from histological reports from their colonoscopy would be collected by research coordinators in order to ascertain ADR, Adenoma Detection Per Colonoscopy (ADPC) and Polyp Detection Rate (PDR).\n\nThese coordinators are independent of the study team and will not be part of the analysis of the data. In order to have an effective barrier (for the study team not to be able to identify the patients from the data collected), therefore the coordinators act as a trusted independent party who will extract/de-identify the data before it is handed to the study team for analysis of the ADR ADPC and PDR. The study team will not attempt to re- identify the patients back.\n\nAnalysis of data:\n\nSubsequent analysis will be conducted at every 3 months by reviewing for the absolute ADR and ADPC amongst endoscopists by the study team. By comparing these prospectively collected data with the historical cohort data, the investigators would be able to evaluate the effectiveness of the GI Genius in improving the ADR, PDR and ADPC. Cost analysis can also be done to analyse the cost effectiveness of the added AI feature."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "This study will be a single-institution cohort study, conducted over a 2-year period. We will recruit patients prospectively who would have their colonoscopy performed with AI guidance from the GI Genius, which is a standard of care feature in the endoscopy rooms fitted with the GI Genius, and compare it against historical data when the AI technology was not available (Jan 2018-Jan 2021). This historical data has already been collected as part of a published audit performed for SKH's endoscopy. The data collected for this historical cohort are from an anonymised database collected from OTMU (who is not involved in the study).", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all adult patients going for colonoscopy in the our institution\n\nExclusion Criteria:\n\n* Patients with incomplete or failed colonoscopy, flexible sigmoidoscopy, colonoscopy done after previous colorectal cancers or previous colonic resections, patients with poor bowel preparation, when deemed by the endoscopist to have an incomplete assessment of the colon'}, 'identificationModule': {'nctId': 'NCT05822895', 'acronym': 'COPILOT', 'briefTitle': 'Review of the Impact of a Computer-aided Real-time Polyp Detection System on Adult Colonoscopy', 'organization': {'class': 'OTHER', 'fullName': 'Sengkang General Hospital'}, 'officialTitle': 'A Comprehensive Review of the Impact of a COmPuter-aIded reaL-time pOlyp deTection System on Adult Colonoscopy (COPILOT Study) - a Single Institution Adoption Experience', 'orgStudyIdInfo': {'id': '2022/2695'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Computer-aided polyp detection', 'description': 'patients undergoing colonoscopy with CADe enabled programme', 'interventionNames': ['Device: CADe enabled programme (GI Genius)']}, {'label': 'without CADe', 'description': 'patients undergoing colonoscopy without CADe enabled programme'}], 'interventions': [{'name': 'CADe enabled programme (GI Genius)', 'type': 'DEVICE', 'description': 'CADe enabled programme (GI Genius)', 'armGroupLabels': ['Computer-aided polyp detection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '544886', 'city': 'Singapore', 'status': 'RECRUITING', 'country': 'Singapore', 'contacts': [{'name': 'Frederick H Koh, FRCSEd', 'role': 'CONTACT', 'email': 'frederick.koh.h.x@singhealth.com.sg', 'phone': '84281117', 'phoneExt': '65'}], 'facility': 'Sengkang General Hospital', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'centralContacts': [{'name': 'Frederick H Koh, FRCSEd', 'role': 'CONTACT', 'email': 'frederick.koh.h.x@singhealth.com.sg', 'phone': '+65-84281117'}], 'overallOfficials': [{'name': 'Frederick H Koh, FRCSEd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sengkang General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sengkang General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medtronic', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}