Effectiveness of Using the Speedometer During Colonoscopy

Norwegian Department of Health and Social Affairs

Status: Unknown

Conditions: Colonic Polyp; Colonic Adenoma; Adenoma Colon

Treatments: Device: Speedometer

Study type: Interventional

Funder types: Other

Identifiers

NCT04710251

2020P001156

Details and patient eligibility

About

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).

Enrollment: 332 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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332 participants in 2 patient groups

Colonoscopy with the speedometer

Active Comparator group

Treatment:

Device: Speedometer

Colonoscopy without the speedometer

No Intervention group