Ignite Creation Date:
2025-12-24 @ 6:52 PM
Ignite Modification Date:
2025-12-30 @ 2:21 AM
Study NCT ID:
NCT00935857
Status:
TERMINATED
Last Update Posted:
2014-09-25
First Post:
2009-07-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Balloon Colonoscopy for Incomplete Colonoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004240', 'term': 'Diverticulum'}], 'ancestors': [{'id': 'D000076385', 'term': 'Diverticular Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'raj-keswani@northwestern.edu', 'phone': '312-695-5620', 'title': 'Rajesh N. Keswani', 'organization': 'Northwestern University'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Early termination due to interim analysis showing statistical difference; single operator.'}}, 'adverseEventsModule': {'timeFrame': '1 week after completion of endoscopy procedure.', 'description': 'All subjects were called 1 week after completion of procedure to assess for adverse events.', 'eventGroups': [{'id': 'EG000', 'title': 'Standard Colonoscopy', 'description': 'Patients who are randomized to received standard colonoscopy as initial treatment.', 'otherNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Single Balloon Colonoscopy', 'description': 'Patients who are randomized to received single balloon colonoscopy as initial treatment.', 'otherNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Complete Colonoscopy to the Cecum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Balloon Colonoscopy', 'description': 'Colonoscopy using the single balloon enteroscope system.'}, {'id': 'OG001', 'title': 'Standard Colonoscopy', 'description': 'Colonoscopy using a standard adult colonoscope'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day of Procedure', 'description': 'Number of patients with a complete colonoscopy to the cecum', 'unitOfMeasure': 'patients', 'populationDescription': 'Per Protocol, Terminated at Interim Analysis'}, {'type': 'SECONDARY', 'title': 'Time (Minutes) to Cecum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Balloon Colonoscopy', 'description': 'Colonoscopy using the single balloon enteroscope system.'}, {'id': 'OG001', 'title': 'Standard Colonoscopy', 'description': 'Colonoscopy using a standard adult colonoscope'}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'spread': '15', 'groupId': 'OG000'}, {'value': '22', 'spread': '18', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day of Procedure', 'description': 'Time, in minutes, until reaching cecum in each arm.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation'}, {'type': 'SECONDARY', 'title': 'Procedural Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Balloon Colonoscopy', 'description': 'Colonoscopy using the single balloon enteroscope system.'}, {'id': 'OG001', 'title': 'Standard Colonoscopy', 'description': 'Colonoscopy using a standard adult colonoscope'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '7 days post procedure', 'description': 'Number of patients with any procedural complications as assessed 7 days after procedure.', 'unitOfMeasure': 'participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Balloon Colonoscopy', 'description': 'Colonoscopy using the single balloon enteroscope system.'}, {'id': 'FG001', 'title': 'Standard Colonoscopy', 'description': 'Colonoscopy using a standard adult colonoscope'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Subject recruitment completed.', 'preAssignmentDetails': 'Early termination at 30 patients due to clinically significant differences at midpoint of study.\n\nPatients in the Standard Colonoscopy group could cross-over to the Balloon Colonoscopy group after 20 minutes of procedure time but they were not included in further analysis after cross-over.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Balloon Colonoscopy', 'description': 'Colonoscopy using the single balloon enteroscope system.'}, {'id': 'BG001', 'title': 'Standard Colonoscopy', 'description': 'Colonoscopy using a standard adult colonoscope'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.5', 'spread': '12.5', 'groupId': 'BG000'}, {'value': '59.9', 'spread': '10.0', 'groupId': 'BG001'}, {'value': '59.2', 'spread': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'An interim analysis was performed at 30 patients as described in initial protocol. The study was terminated at the interim analysis.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'whyStopped': 'Significant difference at interim analysis', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-09-23', 'studyFirstSubmitDate': '2009-07-07', 'resultsFirstSubmitDate': '2012-12-03', 'studyFirstSubmitQcDate': '2009-07-07', 'lastUpdatePostDateStruct': {'date': '2014-09-25', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-09-23', 'studyFirstPostDateStruct': {'date': '2009-07-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-09-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete Colonoscopy to the Cecum', 'timeFrame': 'Day of Procedure', 'description': 'Number of patients with a complete colonoscopy to the cecum'}], 'secondaryOutcomes': [{'measure': 'Time (Minutes) to Cecum', 'timeFrame': 'Day of Procedure', 'description': 'Time, in minutes, until reaching cecum in each arm.'}, {'measure': 'Procedural Complications', 'timeFrame': '7 days post procedure', 'description': 'Number of patients with any procedural complications as assessed 7 days after procedure.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Balloon Enteroscopy', 'Looping'], 'conditions': ['Diverticulosis']}, 'descriptionModule': {'briefSummary': 'Patients with a prior incomplete colonoscopy will be enrolled in this study. Patients will be randomized to either an initial repeat attempt with a standard colonoscope or the single balloon enteroscope. If the procedures is unsuccessful, the patient can be crossed-over to the other group. The primary endpoint of the study is a complete colonoscopy.', 'detailedDescription': 'Colonoscopy is a well-established practice utilized for the evaluation of lower gastrointestinal tract diseases including, mostly commonly, the screening for colorectal polyps and cancer. Despite improvements in endoscope technology, a significant minority of procedures (up to 10%) can not be safely completed due to a variety of patient factors and technical difficulties. These factors primarily include prior abdominal surgeries resulting in adhesions, severe diverticular disease, inadequate bowel cleansing, and patient discomfort.\n\nOptions for an incomplete colonoscopy include several endoscopic and non-endoscopic modalities. Non-endoscopic modalities include radiologic studies such as CT/MRI colonography as well as a retrograde barium study. Relative disadvantages of these modalities is the inability to remove colonic polyps, perform biopsies, and in the case of barium studies, a lower sensitivity for pathology. Alternative endoscopic modalities have been described that may assist in successfully completing colonoscopy Of these alternative methods, balloon-overtube assisted colonoscopy is the most promising, but this method has not been studied in a randomized, controlled fashion. In this study, we aim to compare balloon-overtube assisted colonoscopy versus standard colonoscopy for patients with prior incomplete colonoscopy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* prior colonoscopy that was incomplete within the previous 12 months or their two most recent colonoscopies (performed at any time interval) were incomplete\n\nExclusion Criteria:\n\n* incomplete colonoscopy due only to poor bowel preparation or inadequate sedation'}, 'identificationModule': {'nctId': 'NCT00935857', 'briefTitle': 'Balloon Colonoscopy for Incomplete Colonoscopy', 'organization': {'class': 'OTHER', 'fullName': 'Northwestern University'}, 'officialTitle': 'Balloon Colonoscopy Versus Repeat Standard Colonoscopy for Prior Incomplete Colonoscopy: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'STU00008540'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Balloon Colonoscopy', 'description': 'Colonoscopy using the single balloon colonoscopy system (novel endoscope to facilitate difficult colonoscopy).', 'interventionNames': ['Device: Single Balloon Colonoscopy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Colonoscopy', 'description': 'Colonoscopy using a standard adult colonoscope', 'interventionNames': ['Device: Standard Colonoscopy']}], 'interventions': [{'name': 'Single Balloon Colonoscopy', 'type': 'DEVICE', 'description': 'Use of the single balloon enteroscopy system (enteroscope and balloon-overtube) to complete colonoscopy.', 'armGroupLabels': ['Balloon Colonoscopy']}, {'name': 'Standard Colonoscopy', 'type': 'DEVICE', 'description': 'Use of the standard adult colonoscope to complete colonoscopy.', 'armGroupLabels': ['Standard Colonoscopy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University Feinberg School of Medicine', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Rajesh N Keswani, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwestern University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwestern University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Medicine', 'investigatorFullName': 'Rajesh Keswani', 'investigatorAffiliation': 'Northwestern University'}}}}