Effectiveness of Using the Speedometer During Colonoscopy

NCT ID: NCT04710251

Last Updated: 2021-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

332 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2022-12-31

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).

Detailed Description

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Conditions

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Colonic Polyp Colonic Adenoma Adenoma Colon

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Colonoscopy with the speedometer

Group Type ACTIVE_COMPARATOR

Speedometer

Intervention Type DEVICE

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

Colonoscopy without the speedometer

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Speedometer

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

Intervention Type DEVICE

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beth Israel Deaconess Medical Center

OTHER

Sponsor Role collaborator

Oslo University Hospital

OTHER

Sponsor Role collaborator

University of Oslo

OTHER

Sponsor Role collaborator

Showa University

OTHER

Sponsor Role collaborator

Norwegian Department of Health and Social Affairs

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

References

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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.

Reference Type DERIVED
PMID: 36519564 (View on PubMed)

Other Identifiers

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2020P001156

Identifier Type: -

Identifier Source: org_study_id

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