Ignite Creation Date:
2025-12-24 @ 3:22 PM
Ignite Modification Date:
2025-12-28 @ 6:55 AM
Study NCT ID:
NCT01969292
Status:
TERMINATED
Last Update Posted:
2016-08-19
First Post:
2013-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Colometer - A Real Time Quality Improvement Feedback System for Screening Colonoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003110', 'term': 'Colonic Neoplasms'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 79}}, 'statusModule': {'whyStopped': 'Stage 1 Complete; Stage 2 and 3 not pursued', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-17', 'studyFirstSubmitDate': '2013-09-26', 'studyFirstSubmitQcDate': '2013-10-21', 'lastUpdatePostDateStruct': {'date': '2016-08-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-10-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '%Clear', 'timeFrame': 'Measurement will occur during the withdrawal phase as indicated by the physician during the colonoscopy procedure; on average, 12 minutes', 'description': 'This is defined as the Percentage of the total withdrawal time where the withdrawal velocity is below a set speed limit and the view is clear (ie, not blurry) as measured by the software. Visualization of the colon lumen is ideal with a slow, non-blurry view in order to detect polyps.'}], 'secondaryOutcomes': [{'measure': 'Average withdrawal velocity', 'timeFrame': 'Measurement will occur during the withdrawal phase as indicated by the physician during the colonoscopy procedure; on average, 12 minutes.'}, {'measure': 'Ottawa Stool Score', 'timeFrame': 'Measurement will occur during the withdrawal phase as indicated by the physician during the colonoscopy procedure; on average, 12 minutes.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['colonoscopy', 'quality assurance'], 'conditions': ['Colon Cancer']}, 'descriptionModule': {'briefSummary': 'Our team has created an automated, real-time software based image analysis tool called Colometer to improve screening colonoscopy providing real time visual feedback on image quality. There are three components to this study. The first is to validate the bowel assessment preparation using the recorded colonoscopy videos from 50 consented normal risk patients. In the second phase, technological and machine user interface refinements will be identified and completed. Finally, the third phase will be a sham controlled prospective study of Colometer versus standard care in 100 consented average risk patients undergoing screening colonoscopy as performed by 10 consented endoscopists.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients: patients categorized as normal risk who have been referred for screening colonoscopy at the Forzani \\& MacPhail Colon Cancer Screening Centre in Calgary, Alberta\n* Endoscopists: Gastroenterologists with practices at the Forzani \\& MacPhail Colon Cancer Screening Centre, Calgary, Alberta\n\nExclusion Criteria:\n\n* Patients: patients who are not categorized as normal risk'}, 'identificationModule': {'nctId': 'NCT01969292', 'briefTitle': 'Colometer - A Real Time Quality Improvement Feedback System for Screening Colonoscopy', 'organization': {'class': 'OTHER', 'fullName': 'University of Calgary'}, 'officialTitle': 'Colometer - A Real Time Quality Improvement Feedback System for Screening Colonoscopy', 'orgStudyIdInfo': {'id': 'Col001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Colometer', 'description': 'Colometer software will be engaged during the colonoscopy to provide real time feedback to the endoscopist.', 'interventionNames': ['Other: Colometer']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham Software', 'description': 'An identical set-up to the experimental arm but with a green band showing across the top for the duration of the colonoscopy.', 'interventionNames': ['Other: Sham Software']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Recordings of colonoscopies made without Colometer or sham feedback during the course of the colonoscopy will be evaluated retrospectively using the Colometer software.'}], 'interventions': [{'name': 'Colometer', 'type': 'OTHER', 'description': 'Real time software based image analysis tool.', 'armGroupLabels': ['Colometer']}, {'name': 'Sham Software', 'type': 'OTHER', 'description': 'Software that displays constant positive feedback that is unrelated to the quality measures of the actual colonoscopy.', 'armGroupLabels': ['Sham Software']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T2N 4Z6', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Forzani&MacPhail Colon Cancer Screening Centre', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}], 'overallOfficials': [{'name': 'Christopher N Andrews, MD MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Calgary'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Christopher Andrews', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Christopher Andrews', 'investigatorAffiliation': 'University of Calgary'}}}}