Effectiveness of Using the Speedometer During Colonoscopy
NCT ID: NCT04710251
Last Updated: 2021-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
332 participants
INTERVENTIONAL
2021-03-01
2022-12-31
Brief Summary
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Objective:
To 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.
Hypothesis:
The 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.
Endpoint: Withdrawal time difference between colonoscopies done without the speedometer (control period) and colonoscopies done with the speedometer (intervention period).
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
DIAGNOSTIC
DOUBLE
Study Groups
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Colonoscopy with the speedometer
Speedometer
We will measure and monitor the withdrawal time of colonoscopy with a speedometer.
Colonoscopy without the speedometer
No interventions assigned to this group
Interventions
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Speedometer
We will measure and monitor the withdrawal time of colonoscopy with a speedometer.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Beth Israel Deaconess Medical Center
OTHER
Oslo University Hospital
OTHER
University of Oslo
OTHER
Showa University
OTHER
Norwegian Department of Health and Social Affairs
OTHER_GOV
Responsible Party
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References
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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.
Other Identifiers
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2020P001156
Identifier Type: -
Identifier Source: org_study_id
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