Effectiveness of Using the Speedometer During Colonoscopy

NCT04710251 | Unknown

• 1 other identifier: 2020P001156
• Study Type: interventional
• Target: 332
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Colonic Polyp; Colonic Adenoma; Adenoma Colon

Keywords

Colonoscopy; Adenoma detection rate; Withdrawal time; Artificial Intelligence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Adenoma detection rate (ADR)

  Through study completion, an average of 1 year

• Quality of colonoscopy

  Through study completion, an average of 1 year

Study Arms (2)

Colonoscopy with the speedometer

ACTIVE COMPARATOR

Device: Speedometer

Colonoscopy without the speedometer

NO INTERVENTION

Interventions

Speedometer DEVICE

We will measure and monitor the withdrawal time of colonoscopy with a speedometer.

Colonoscopy with the speedometer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Both women and men aged 18 years or older undergoing colonoscopy for any indication at Beth Israel Deaconess Medical Center (BIDMC), Boston, USA.

You may not qualify if:

• Known colorectal cancer, hereditary colorectal polyposis, inflammatory bowel disease, or past history of colectomy.

Sponsors & Collaborators

• Norwegian Department of Health and Social Affairs: lead
• Beth Israel Deaconess Medical Center: collaborator
• Oslo University Hospital: collaborator
• University of Oslo: collaborator
• Showa University: collaborator

Related Publications (1)

• 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.

  PMID: 36519564 DERIVED

MeSH Terms

Conditions

Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2021
• First Posted: January 14, 2021
• Study Start: March 1, 2021
• Primary Completion: June 30, 2021
• Study Completion: December 31, 2022
• Last Updated: January 14, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share