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Effectiveness of Using the Speedometer During Colonoscopy

NCT04710251 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 332

Last updated 2021-01-14

No results posted yet for this study

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

Interventions

DEVICE

Speedometer

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

Sponsors & Collaborators

  • Beth Israel Deaconess Medical Center

    collaborator OTHER

  • Oslo University Hospital

    collaborator OTHER

  • University of Oslo

    collaborator OTHER

  • Showa University

    collaborator OTHER

  • Norwegian Department of Health and Social Affairs

    lead OTHER_GOV

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-01
Primary Completion
2021-06-30
Completion
2022-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04710251 on ClinicalTrials.gov