Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2026-01-01 @ 1:50 AM
Study NCT ID:
NCT01895504
Status:
COMPLETED
Last Update Posted:
2015-03-04
First Post:
2013-07-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ColoAssist vs. MEI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D000236', 'term': 'Adenoma'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 475}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-02', 'studyFirstSubmitDate': '2013-07-04', 'studyFirstSubmitQcDate': '2013-07-09', 'lastUpdatePostDateStruct': {'date': '2015-03-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cecal intubation rate', 'timeFrame': '1 hour', 'description': 'The ability to reach the cecum during colonoscopy'}], 'secondaryOutcomes': [{'measure': 'Cecal intubation time', 'timeFrame': '1 hour', 'description': 'Time to reach the cecum during colonoscopy'}, {'measure': 'Adenoma detection rate', 'timeFrame': '1 hour', 'description': 'The proportion of participants in whom at least one adenoma is detected'}, {'measure': 'Polyp detection rate', 'timeFrame': '1 hour', 'description': 'The proportion of participants in whom at least one polyp i detected'}, {'measure': 'Pain', 'timeFrame': '24 hours', 'description': 'Participants will be asked to score discomfort or pain during and after colonoscopy'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Colonoscopy', 'Colorectal cancer', 'Adenoma'], 'conditions': ['Colorectal Cancer', 'Screening']}, 'referencesModule': {'references': [{'pmid': '28405331', 'type': 'DERIVED', 'citation': 'Garborg K, Wiig H, Hasund A, Matre J, Holme O, Noraberg G, Loberg M, Kalager M, Adami HO, Bretthauer M. Gradual stiffness versus magnetic imaging-guided variable stiffness colonoscopes: A randomized noninferiority trial. United European Gastroenterol J. 2017 Feb;5(1):128-133. doi: 10.1177/2050640616639162. Epub 2016 Jun 23.'}]}, 'descriptionModule': {'briefSummary': 'Colonoscopy aims to investigate the entire colon by advancing the colonoscope tip from the rectum to the cecum, a process called cecal intubation. Cecal intubation may be difficult for different reasons, and features of the colonoscope and the use of imaging devices may influence the success rate. We want to compare the performance of a new colonoscope with novel features including gradual stiffness with that of a colonoscope supplied with a magnetic endoscope imaging (MEI) device. The hypothesis is that the performance of the new instrument is non-inferior to the MEI system.', 'detailedDescription': 'The recommended cecal intubation rate in colorectal cancer (CRC) screening is 95%. The MEI system allows real time monitoring of the colonoscope position within the colon and is considered to be a useful supplement to achieve cecal intubation. However, the MEI system is costly, and trial results are equivocal regarding the actual benefits. A newly designed colonoscope (ColoAssist) with gradual stiffness throughout the colonoscope shaft has been developed to improve insertability. We want to investigate if we can achieve equal performance results with the ColoAssist instrument as with the MEI system in CRC screening. The study is designed as a two-center, single-blinded, randomized, controlled non-inferiority trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '66 Years', 'minimumAge': '55 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inclusion in an ongoing colorectal cancer screening trial (NCT 00883792)\n\nExclusion Criteria:\n\n* Excluded from the ongoing screening trial (NCT 00883792)\n* Inability or unwilling to provide informed consent'}, 'identificationModule': {'nctId': 'NCT01895504', 'briefTitle': 'ColoAssist vs. MEI', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sorlandet Hospital HF'}, 'officialTitle': 'ColoAssist vs. Magnetic Guided Colonoscopy - a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'ColoAssist'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ColoAssist', 'description': 'Screening colonoscopy with a new colonoscope with gradual stiffness', 'interventionNames': ['Device: ColoAssist']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'MEI', 'description': 'Screening colonoscopy with colonoscopes compatible with and guided by MEI', 'interventionNames': ['Device: MEI']}], 'interventions': [{'name': 'ColoAssist', 'type': 'DEVICE', 'otherNames': ['FujiFilm EC-590WI4'], 'description': 'Screening colonoscopy with the test instrument', 'armGroupLabels': ['ColoAssist']}, {'name': 'MEI', 'type': 'DEVICE', 'otherNames': ['Olympus ScopeGuide'], 'description': 'Colonoscopy with Olympus colonoscopes and MEI guidance', 'armGroupLabels': ['MEI']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Arendal', 'country': 'Norway', 'facility': 'SSHF Arendal', 'geoPoint': {'lat': 58.46151, 'lon': 8.77253}}, {'zip': '4604', 'city': 'Kristiansand', 'country': 'Norway', 'facility': 'SSHF Kristiansand', 'geoPoint': {'lat': 58.14671, 'lon': 7.9956}}], 'overallOfficials': [{'name': 'Kjetil K Garborg, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'SSHF Kristiansand, Norway'}, {'name': 'Michael Bretthauer, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Oslo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sorlandet Hospital HF', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}