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NCT04710251 Clinical Trial

Effectiveness of Using the Speedometer During Colonoscopy

Colonic Polyp Clinical Trial

Official title:
Effectiveness of Using the Speedometer During Colonoscopy: a Prospective, Comparative Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04710251
Other study ID # 2020P001156
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date March 1, 2021
Est. completion date December 31, 2022

Study information
Verified date January 2021
Source Norwegian Department of Health and Social Affairs
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

PURPOSE OF PROTOCOL 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).

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 332
Est. completion date December 31, 2022
Est. primary completion date June 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Both women and men aged 18 years or older undergoing colonoscopy for any indication at Beth Israel Deaconess Medical Center (BIDMC), Boston, USA. Exclusion Criteria: - Known colorectal cancer, hereditary colorectal polyposis, inflammatory bowel disease, or past history of colectomy.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Speedometer
We will measure and monitor the withdrawal time of colonoscopy with a speedometer.

Locations
Country Name City State
n/a

Sponsors (5)
Lead Sponsor Collaborator
Norwegian Department of Health and Social Affairs Beth Israel Deaconess Medical Center, Oslo University Hospital, Showa University, University of Oslo

Outcome
Type Measure Description Time frame Safety issue
Primary Withdrawal time Withdrawal time difference between colonoscopies done without the speedometer (control period) and colonoscopies done with the speedometer (intervention period). Through study completion, an average of 1 year
Secondary Adenoma detection rate (ADR) Adenoma detection rate (ADR) of the participating endoscopists during the control period and the intervention period. Through study completion, an average of 1 year
Secondary Quality of colonoscopy Proportion of colonoscopies with withdrawal time = 6 minutes. Through study completion, an average of 1 year
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