Ignite Creation Date:
2025-12-24 @ 9:25 PM
Ignite Modification Date:
2025-12-29 @ 5:32 PM
Study NCT ID:
NCT01126632
Status:
WITHDRAWN
Last Update Posted:
2016-01-28
First Post:
2010-05-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Will Cap-Assisted Colonoscopy Improve Performance of Colonoscopy: A Randomized Clinical Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Caps became unavailable by manufacturer', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-27', 'studyFirstSubmitDate': '2010-05-15', 'studyFirstSubmitQcDate': '2010-05-18', 'lastUpdatePostDateStruct': {'date': '2016-01-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cap-assisted colonoscopy compared visibility with standard colonoscopy', 'timeFrame': '4 months', 'description': 'Propose to perform a randomized controlled trial comparing cap-assisted colonoscopy with the standard colonoscopy to assess visibility. To see if it is easier to detect polyps, adenomas with the cap than without. This is standard procedure. Just comparing if it is better to use the cap during colonoscopy.'}], 'secondaryOutcomes': [{'measure': 'Polyp detection rate', 'timeFrame': '4 months', 'description': 'Number of Polyps detected per procedure using the cap. To see if it is more visible.'}, {'measure': 'Adenoma Detection', 'timeFrame': '4 months', 'description': 'number of adenomatous polyps detected per procedure. To see if it is more visible using the cap as to not using the cap.'}, {'measure': 'Advanced lesion detection rate', 'timeFrame': '4 months', 'description': '(number of advanced lesions per procedure) defined as lesions with high-grade dysplasia, greater than 1 cm. size. To see if it is more visible using the cap as to not using the cap.'}, {'measure': 'Cecal Intubation Rate', 'timeFrame': '4 months', 'description': 'Time to cecum'}, {'measure': 'Total time for colonoscopy', 'timeFrame': '4 months'}, {'measure': 'Complication Rate', 'timeFrame': '4 months', 'description': 'Amount of complications during colonoscopies'}, {'measure': 'Procedure indication', 'timeFrame': '4 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Colonoscopy'], 'conditions': ['Colonoscopy']}, 'referencesModule': {'references': [{'pmid': '19098847', 'type': 'RESULT', 'citation': 'Lee YT, Lai LH, Hui AJ, Wong VW, Ching JY, Wong GL, Wu JC, Chan HL, Leung WK, Lau JY, Sung JJ, Chan FK. Efficacy of cap-assisted colonoscopy in comparison with regular colonoscopy: a randomized controlled trial. Am J Gastroenterol. 2009 Jan;104(1):41-6. doi: 10.1038/ajg.2008.56.'}]}, 'descriptionModule': {'briefSummary': 'Observing the effects of an Olympus cap on the visibility and in adenoma detection during colonoscopy.', 'detailedDescription': 'To see if Colonoscopy with the CAP is able to give more visibility and to see if detection rate for adenomas, polyps are easier to detect.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Endoscopy Clinic- Patients already receiving colonoscopies', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients already booked for a colonoscopy\n\nExclusion Criteria:\n\n* History of Colorectal Cancer\n* Severe colitis\n* Cancer\n* poor bowel prep'}, 'identificationModule': {'nctId': 'NCT01126632', 'acronym': 'CAC', 'briefTitle': 'Will Cap-Assisted Colonoscopy Improve Performance of Colonoscopy: A Randomized Clinical Trial', 'organization': {'class': 'OTHER', 'fullName': 'Nova Scotia Health Authority'}, 'officialTitle': 'Will Cap-Assisted Colonoscopy Improve Performance of Colonoscopy: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'CAC Study'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cap Assisted Colonoscopy', 'description': 'Patients receiving colonoscopies where scope is fitted with cap'}, {'label': 'Standard Colonoscopy', 'description': 'Patients receiving standard colonoscopy without the cap on the scope'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'B3H 2Y9', 'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'Capital District Health Authority', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}], 'overallOfficials': [{'name': 'Donald G MacIntosh, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nova Scotia Health Authority'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Study was terminated'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nova Scotia Health Authority', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}