Effectiveness of Using the Speedometer During Colonoscopy

Not Applicable

• Conditions: Colonic Polyp; Colonic Adenoma; Adenoma Colon
• Interventions: Device: Speedometer

• Registration Number: NCT04710251
• Lead Sponsor: Norwegian Department of Health and Social Affairs

Brief 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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-01
• Study First Submitted: 2021-01-11
• Study First Submitted QC: 2021-01-12
• Last Update Submitted: 2021-01-12
• Study First Posted: 2021-01-14
• Last Update Posted: 2021-01-14
• Study Start: 2021-03-01
• Primary Completion: 2021-06-30
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 332

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

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Colonoscopy with the speedometer	Speedometer	-

Primary Outcome Measures

Name	Time	Method
Withdrawal time	Through study completion, an average of 1 year	Withdrawal time difference between colonoscopies done without the speedometer (control period) and colonoscopies done with the speedometer (intervention period).

Secondary Outcome Measures

Name	Time	Method
Adenoma detection rate (ADR)	Through study completion, an average of 1 year	Adenoma detection rate (ADR) of the participating endoscopists during the control period and the intervention period.
Quality of colonoscopy	Through study completion, an average of 1 year	Proportion of colonoscopies with withdrawal time ≥ 6 minutes.