Effectiveness of Using the Speedometer During Colonoscopy

Study Overview
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Brief Summary
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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).

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

Conditions
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Colonic Polyp, Colonic Adenoma, Adenoma Colon

Intervention / Treatment
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* Device: Speedometer


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Colonoscopy with the speedometer<br> | Device: Speedometer<br>* We will measure and monitor the withdrawal time of colonoscopy with a speedometer.<br>|
| No Intervention: Colonoscopy without the speedometer<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Quality of colonoscopy | Proportion of colonoscopies with withdrawal time ≥ 6 minutes. | Through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colonoscopy, Adenoma detection rate, Withdrawal time, Artificial Intelligence