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Effectiveness of Using the Speedometer During Colonoscopy

Primary Purpose

Colonic Polyp, Colonic Adenoma, Adenoma Colon

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Speedometer
Sponsored by
Norwegian Department of Health and Social Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Colonic Polyp focused on measuring Colonoscopy, Adenoma detection rate, Withdrawal time, Artificial Intelligence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    Colonoscopy with the speedometer

    Colonoscopy without the speedometer

    Arm Description

    Outcomes

    Primary Outcome Measures

    Withdrawal time
    Withdrawal time difference between colonoscopies done without the speedometer (control period) and colonoscopies done with the speedometer (intervention period).

    Secondary Outcome Measures

    Adenoma detection rate (ADR)
    Adenoma detection rate (ADR) of the participating endoscopists during the control period and the intervention period.
    Quality of colonoscopy
    Proportion of colonoscopies with withdrawal time ≥ 6 minutes.

    Full Information

    First Posted
    January 11, 2021
    Last Updated
    January 12, 2021
    Sponsor
    Norwegian Department of Health and Social Affairs
    Collaborators
    Beth Israel Deaconess Medical Center, Oslo University Hospital, University of Oslo, Showa University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04710251
    Brief Title
    Effectiveness of Using the Speedometer During Colonoscopy
    Official Title
    Effectiveness of Using the Speedometer During Colonoscopy: a Prospective, Comparative Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 1, 2021 (Anticipated)
    Primary Completion Date
    June 30, 2021 (Anticipated)
    Study Completion Date
    December 31, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Norwegian Department of Health and Social Affairs
    Collaborators
    Beth Israel Deaconess Medical Center, Oslo University Hospital, University of Oslo, Showa University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Colonic Polyp, Colonic Adenoma, Adenoma Colon
    Keywords
    Colonoscopy, Adenoma detection rate, Withdrawal time, Artificial Intelligence

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Sequential Assignment
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Non-Randomized
    Enrollment
    332 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Colonoscopy with the speedometer
    Arm Type
    Active Comparator
    Arm Title
    Colonoscopy without the speedometer
    Arm Type
    No Intervention
    Intervention Type
    Device
    Intervention Name(s)
    Speedometer
    Intervention Description
    We will measure and monitor the withdrawal time of colonoscopy with a speedometer.
    Primary Outcome Measure Information:
    Title
    Withdrawal time
    Description
    Withdrawal time difference between colonoscopies done without the speedometer (control period) and colonoscopies done with the speedometer (intervention period).
    Time Frame
    Through study completion, an average of 1 year
    Secondary Outcome Measure Information:
    Title
    Adenoma detection rate (ADR)
    Description
    Adenoma detection rate (ADR) of the participating endoscopists during the control period and the intervention period.
    Time Frame
    Through study completion, an average of 1 year
    Title
    Quality of colonoscopy
    Description
    Proportion of colonoscopies with withdrawal time ≥ 6 minutes.
    Time Frame
    Through study completion, an average of 1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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