Effectiveness of Using the Speedometer During Colonoscopy

January 12, 2021 updated by: Norwegian Department of Health and Social Affairs

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

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

332

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Withdrawal time
Time Frame: 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).
Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adenoma detection rate (ADR)
Time Frame: Through study completion, an average of 1 year
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
Time Frame: Through study completion, an average of 1 year
Proportion of colonoscopies with withdrawal time ≥ 6 minutes.
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norwegian Department of Health and Social Affairs

Collaborators

University of Oslo
Oslo University Hospital
Beth Israel Deaconess Medical Center
Showa University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2021

Primary Completion (Anticipated)

June 30, 2021

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

January 11, 2021

First Submitted That Met QC Criteria

January 12, 2021

First Posted (Actual)

January 14, 2021

Study Record Updates

Last Update Posted (Actual)

January 14, 2021

Last Update Submitted That Met QC Criteria

January 12, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020P001156

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Colonic Polyp

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Türkiye

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe