Ignite Creation Date:
2025-12-25 @ 12:58 AM
Ignite Modification Date:
2026-03-11 @ 10:29 PM
Study NCT ID:
NCT02826993
Status:
COMPLETED
Last Update Posted:
2021-09-10
First Post:
2016-05-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patients With Incomplete Colonoscopy a Comparison of Colon Capsule Endoscopy and CT Colonography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2019-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-07', 'studyFirstSubmitDate': '2016-05-20', 'studyFirstSubmitQcDate': '2016-07-07', 'lastUpdatePostDateStruct': {'date': '2021-09-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity and specificity of CCE compared to CTC', 'timeFrame': 'Up to 14 days for conducting both procedures', 'description': 'The sensitivity and specificity of CCE will be measured in terms of n of polyps detected by CCE compared to n of polyps detected by CTC'}], 'secondaryOutcomes': [{'measure': 'Size estimation', 'timeFrame': 'Up to 14 days for conducting both procedures', 'description': 'Each polyp is estimated in terms of size through the use of both technologies'}, {'measure': 'Polyp miss rate', 'timeFrame': 'Up to 30 days for conducting all three procedures', 'description': 'The rate of polyps missed by CCE and CTC respectively compared to a colonoscopy that will be performed in full sedation for participants in whom discrepancy is found between the two modalities (CCE and CTC)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['PillCAM2'], 'conditions': ['Incomplete Colonoscopy', 'CT Colonography', 'Camera Capsule Endoscopy']}, 'referencesModule': {'references': [{'pmid': '32731841', 'type': 'DERIVED', 'citation': 'Deding U, Herp J, Havshoei AL, Kobaek-Larsen M, Buijs MM, Nadimi ES, Baatrup G. Colon capsule endoscopy versus CT colonography after incomplete colonoscopy. Application of artificial intelligence algorithms to identify complete colonic investigations. United European Gastroenterol J. 2020 Aug;8(7):782-789. doi: 10.1177/2050640620937593.'}]}, 'descriptionModule': {'briefSummary': 'A total of 8000 colonoscopies are performed on a yearly basis on the Funen Island. Between 5% and 10% of those are incomplete due to excessive pain, fixed colon loops, and other reasons. The current standard procedure is to refer the patient to the department of radiology for a CT-colonography. In some instances the radiology department can offer the investigation the next day, and thus in the same colon preparation. At other times they cannot, and the patient has to go through an second colon preparation for the colonography.\n\nA CCE procedure could be provided to the participants immediately after the failed colonoscopy and the investigation can be completed the next morning in the same bowel preparation without a visit to the radiology department.', 'detailedDescription': 'Optical colonoscopy is the standard method for evaluating the colon. This technique allows evaluation of the entire colon in most patients. Full colonoscopy including examination of the cecum is associated with an increased detection rate of advanced neoplasia, as 33-50% of advanced neoplasia is located in the proximal colon. After an incomplete optical colonoscopy, participants are required to undergo another test in order to exclude clinically relevant lesions to reduce the risk of proximal cancer which has been shown to increase by twofold when colonoscopy was incomplete.\n\nEndoscopic and radiological options to complete the colon assessment have been available in the last decades. Multiple alternative endoscopic techniques-such as colonoscopy with thinner colonoscopes, gastroscopes and device-assisted enteroscopes have been described. However, none of them has been clearly standardized.\n\nCT colonography (CTC), is a relatively new imaging technique that was first described in 1994. In large randomized trials on symptomatic patients, CTC has been shown to be as equally effective as colonoscopy - for the detection of large colorectal polyps and already developed colorectal cancer.\n\nColon Capsule Endoscopy (CCE) is a promising new technology that may have the potential to complement existing diagnostic methods to screen people for colorectal cancer. Delivered correctly, it may reduce costs, increase utilization of medical services, reduce risks for patients and overall improve screening rates among the population.\n\nA total of 8000 colonoscopies are performed on a yearly basis on the Funen Island and about 10% of those are incomplete due to excessive pain, fixed colon loops, and others causes. The current standard procedure is to refer the participant to the Department of Radiology for a CT-colonography.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Incomplete colonoscopy\n\nExclusion Criteria:\n\n* Previous gastrointestinal surgery except for appendectomy\n* Known inflammatory bowel disease including Crohn's disease and ulcerative colitis\n* An ostomy\n* Diabetes\n* Symptoms on bowel obstruction\n* Pacemakers\n* Kidney diseases"}, 'identificationModule': {'nctId': 'NCT02826993', 'acronym': 'CfC100', 'briefTitle': 'Patients With Incomplete Colonoscopy a Comparison of Colon Capsule Endoscopy and CT Colonography', 'organization': {'class': 'OTHER', 'fullName': 'Odense University Hospital'}, 'officialTitle': 'Can Colon Capsule Endoscopy Substitute CT Colonography in the Large Bowel Examination of Persons Whose Colonoscopy Was Incomplete?', 'orgStudyIdInfo': {'id': 'OdenseUH_MKL1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CCE in incomplete Colonoscopies', 'description': 'Patients in which colonoscopy is not possible are invited for CT colonography and those patients are examined by Camera Capsule Endoscopy the day before the CT colonography and the two different examinations are compared.', 'interventionNames': ['Device: CCE in incomplete Colonoscopies']}], 'interventions': [{'name': 'CCE in incomplete Colonoscopies', 'type': 'DEVICE', 'otherNames': ['PillCams2'], 'description': 'When the initial colonoscopy has failed, participants are invited to ingest a CCE on the day prior to their subsequent CT colonography. Thus, the CCE and CT will be compared within subjects for their ability to identify and estimate sizes of polyps', 'armGroupLabels': ['CCE in incomplete Colonoscopies']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5700', 'city': 'Svendborg', 'country': 'Denmark', 'facility': 'Odense University Hospital, Svendborg Sygehus', 'geoPoint': {'lat': 55.05982, 'lon': 10.60677}}], 'overallOfficials': [{'name': 'Gunnar Baatrup, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Odense University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Odense University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Project Coordinator', 'investigatorFullName': 'Morten Kobaek-Larsen', 'investigatorAffiliation': 'Odense University Hospital'}}}}