Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2026-02-24 @ 2:08 PM
Study NCT ID:
NCT04710251
Status:
UNKNOWN
Last Update Posted:
2021-01-14
First Post:
2021-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Using the Speedometer During Colonoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003111', 'term': 'Colonic Polyps'}], 'ancestors': [{'id': 'D007417', 'term': 'Intestinal Polyps'}, {'id': 'D011127', 'term': 'Polyps'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 332}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-12', 'studyFirstSubmitDate': '2021-01-11', 'studyFirstSubmitQcDate': '2021-01-12', 'lastUpdatePostDateStruct': {'date': '2021-01-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Withdrawal time', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Withdrawal time difference between colonoscopies done without the speedometer (control period) and colonoscopies done with the speedometer (intervention period).'}], 'secondaryOutcomes': [{'measure': 'Adenoma detection rate (ADR)', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Adenoma detection rate (ADR) of the participating endoscopists during the control period and the intervention period.'}, {'measure': 'Quality of colonoscopy', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Proportion of colonoscopies with withdrawal time ≥ 6 minutes.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Colonoscopy', 'Adenoma detection rate', 'Withdrawal time', 'Artificial Intelligence'], 'conditions': ['Colonic Polyp', 'Colonic Adenoma', 'Adenoma Colon']}, 'referencesModule': {'references': [{'pmid': '36519564', 'type': 'DERIVED', 'citation': 'Barua I, Misawa M, Glissen Brown JR, Walradt T, Kudo SE, Sheth SG, Nee J, Iturrino J, Mukherjee R, Cheney CP, Sawhney MS, Pleskow DK, Mori K, Loberg M, Kalager M, Wieszczy P, Bretthauer M, Berzin TM, Mori Y. Speedometer for withdrawal time monitoring during colonoscopy: a clinical implementation trial. Scand J Gastroenterol. 2023 Jun;58(6):664-670. doi: 10.1080/00365521.2022.2154616. Epub 2022 Dec 15.'}]}, 'descriptionModule': {'briefSummary': 'PURPOSE OF PROTOCOL\n\nObjective:\n\nTo evaluate if the speedometer based on the real-time image analysis can help endoscopists increase their withdrawal time, which is defined as time spent examining the colon during withdrawal of the colonoscope, during colonoscopy.\n\nHypothesis:\n\nThe trial hypothesis is that use of the speedometer during colonoscopy will increase the average withdrawal time, which is defined as time spent examining the colon during withdrawal of the colonoscope, by 1.6 minutes, possibly increasing the performance of the participating endoscopists. Our objective is to clarify the clinical benefits of this digital tool in colonoscopy.\n\nEndpoint: Withdrawal time difference between colonoscopies done without the speedometer (control period) and colonoscopies done with the speedometer (intervention period).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Both women and men aged 18 years or older undergoing colonoscopy for any indication at Beth Israel Deaconess Medical Center (BIDMC), Boston, USA.\n\nExclusion Criteria:\n\n* Known colorectal cancer, hereditary colorectal polyposis, inflammatory bowel disease, or past history of colectomy.'}, 'identificationModule': {'nctId': 'NCT04710251', 'briefTitle': 'Effectiveness of Using the Speedometer During Colonoscopy', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Norwegian Department of Health and Social Affairs'}, 'officialTitle': 'Effectiveness of Using the Speedometer During Colonoscopy: a Prospective, Comparative Trial', 'orgStudyIdInfo': {'id': '2020P001156'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Colonoscopy with the speedometer', 'interventionNames': ['Device: Speedometer']}, {'type': 'NO_INTERVENTION', 'label': 'Colonoscopy without the speedometer'}], 'interventions': [{'name': 'Speedometer', 'type': 'DEVICE', 'description': 'We will measure and monitor the withdrawal time of colonoscopy with a speedometer.', 'armGroupLabels': ['Colonoscopy with the speedometer']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Norwegian Department of Health and Social Affairs', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Beth Israel Deaconess Medical Center', 'class': 'OTHER'}, {'name': 'Oslo University Hospital', 'class': 'OTHER'}, {'name': 'University of Oslo', 'class': 'OTHER'}, {'name': 'Showa University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}