Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2026-01-02 @ 5:44 PM
Study NCT ID:
NCT03243669
Status:
COMPLETED
Last Update Posted:
2023-01-27
First Post:
2017-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High Definition Endoscopy and Virtual Chromoendoscopy Versus Standard Resolution Endoscopy in Detection of Colon Polyps
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2146}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2014-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-26', 'studyFirstSubmitDate': '2017-07-22', 'studyFirstSubmitQcDate': '2017-08-03', 'lastUpdatePostDateStruct': {'date': '2023-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adenoma detection rate (ADR)', 'timeFrame': '7-10 days', 'description': 'Percentage of colonoscopies with detection of 1 or more adenomas. ADR is a well-established quality indicator in colonoscopy in the prevalence of adenomas detected (ADR) as recommended by American Society for Gastrointestinal Endoscopy (ASGE)/American College of Gastroenterology Task Force (ACGTF) and European Society of Gastrointestinal Endoscopy (ESGE). Guidelines stipulate to use ADR as main quality indicator in colonoscopy.'}], 'secondaryOutcomes': [{'measure': 'Number of adenomas', 'timeFrame': '7-10 days', 'description': 'Adenoma per colonoscopy rate (APCR)'}, {'measure': 'Type of adenomas', 'timeFrame': '7-10 days', 'description': 'Subtypes of adenomas: tubular adenomas, tubulovillous adenomas, sessile serrated adenomas and adenocarcinomas'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Colonoscopy', 'High-definition endoscopy', 'Virtual chromoendoscopy', 'Adenoma detection rate (ADR)'], 'conditions': ['Colonic Adenoma']}, 'referencesModule': {'references': [{'pmid': '25448873', 'type': 'BACKGROUND', 'citation': 'Rex DK, Schoenfeld PS, Cohen J, Pike IM, Adler DG, Fennerty MB, Lieb JG 2nd, Park WG, Rizk MK, Sawhney MS, Shaheen NJ, Wani S, Weinberg DS. Quality indicators for colonoscopy. Am J Gastroenterol. 2015 Jan;110(1):72-90. doi: 10.1038/ajg.2014.385. Epub 2014 Dec 2. No abstract available.'}, {'pmid': '28268235', 'type': 'BACKGROUND', 'citation': 'Kaminski MF, Thomas-Gibson S, Bugajski M, Bretthauer M, Rees CJ, Dekker E, Hoff G, Jover R, Suchanek S, Ferlitsch M, Anderson J, Roesch T, Hultcranz R, Racz I, Kuipers EJ, Garborg K, East JE, Rupinski M, Seip B, Bennett C, Senore C, Minozzi S, Bisschops R, Domagk D, Valori R, Spada C, Hassan C, Dinis-Ribeiro M, Rutter MD. Performance measures for lower gastrointestinal endoscopy: a European Society of Gastrointestinal Endoscopy (ESGE) Quality Improvement Initiative. Endoscopy. 2017 Apr;49(4):378-397. doi: 10.1055/s-0043-103411. Epub 2017 Mar 7.'}]}, 'descriptionModule': {'briefSummary': 'Over the last years a number of new endoscopic imaging modalities have been introduced (high-definition and virtual chromoendoscopy). Given the theoretical advantage of these new imaging techniques, the investigators aimed to investigate their use for the detection of polyps during colonoscopy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* referred for colonoscopy\n* signed informed consent\n\nExclusion Criteria:\n\n* subtotal colectomy\n* known colorectal tumor or polyp prior to colonoscopy\n* genetic predisposition to colon cancer namely FAP, HNPCC, Hyperplastic polyposis syndrome, juvenile polyposis, Peutz-Jeghers syndrome\n* inflammatory bowel disease\n* primary sclerosering cholangitis'}, 'identificationModule': {'nctId': 'NCT03243669', 'briefTitle': 'High Definition Endoscopy and Virtual Chromoendoscopy Versus Standard Resolution Endoscopy in Detection of Colon Polyps', 'organization': {'class': 'OTHER', 'fullName': 'Universitaire Ziekenhuizen KU Leuven'}, 'officialTitle': 'High Definition Endoscopy and Virtual Chromoendoscopy Versus Standard Resolution Endoscopy in Detection of Colon Polyps', 'orgStudyIdInfo': {'id': 'S52580'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Fujinon standard', 'interventionNames': ['Diagnostic Test: Standard']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fujinon HD', 'description': 'Fujinon high-definition', 'interventionNames': ['Diagnostic Test: High-definition']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fujinon HD + VC', 'description': 'Fujinon high-definition + virtual chromoendoscopy', 'interventionNames': ['Diagnostic Test: High-definition', 'Diagnostic Test: Virtual chromoendoscopy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Olympus standard', 'interventionNames': ['Diagnostic Test: Standard']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Olympus HD', 'description': 'Olympus high-definition', 'interventionNames': ['Diagnostic Test: High-definition']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Olympus VC', 'description': 'Olympus virtual chromoendoscopy', 'interventionNames': ['Diagnostic Test: Virtual chromoendoscopy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Olympus HD + VC', 'description': 'Olympus high-definition + virtual chromoendoscopy', 'interventionNames': ['Diagnostic Test: High-definition', 'Diagnostic Test: Virtual chromoendoscopy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pentax standard', 'interventionNames': ['Diagnostic Test: Standard']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pentax HD', 'description': 'Pentax high-definition', 'interventionNames': ['Diagnostic Test: High-definition']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pentax VC', 'description': 'Pentax virtual chromoendoscopy', 'interventionNames': ['Diagnostic Test: Virtual chromoendoscopy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pentax HD + VC', 'description': 'Pentax high-definition + virtual chromoendoscopy', 'interventionNames': ['Diagnostic Test: High-definition', 'Diagnostic Test: Virtual chromoendoscopy']}], 'interventions': [{'name': 'High-definition', 'type': 'DIAGNOSTIC_TEST', 'description': 'High-definition colonoscopy', 'armGroupLabels': ['Fujinon HD', 'Fujinon HD + VC', 'Olympus HD', 'Olympus HD + VC', 'Pentax HD', 'Pentax HD + VC']}, {'name': 'Virtual chromoendoscopy', 'type': 'DIAGNOSTIC_TEST', 'description': 'Virtual chromoendoscopy', 'armGroupLabels': ['Fujinon HD + VC', 'Olympus HD + VC', 'Olympus VC', 'Pentax HD + VC', 'Pentax VC']}, {'name': 'Standard', 'type': 'DIAGNOSTIC_TEST', 'description': 'Standard colonoscopy', 'armGroupLabels': ['Fujinon standard', 'Olympus standard', 'Pentax standard']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'University Hospitals Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}], 'overallOfficials': [{'name': 'Raf Bisschops, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitaire Ziekenhuizen KU Leuven'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitaire Ziekenhuizen KU Leuven', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}