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Status:

COMPLETED

Computer Aided Detection of Polyps in Colonoscopy

Lead Sponsor:

Iterative Scopes, Inc

Collaborating Sponsors:

University of Minnesota

Conditions:

Colorectal Polyp

Eligibility:

All Genders

40+ years

Phase:

NA

Brief Summary

The aim of this study is to evaluate the clinical benefit and safety of using a computer aided detection device, Skout, for real-time polyp detection in colonoscopy procedures with the indication of s...

Eligibility Criteria

Inclusion

  • Inclusion Criteria
  • Participants will be eligible for this study if they are:
  • Undergoing colonoscopy with screening, surveillance, or diagnostic indications.
  • Undergoing a procedure by a participating endoscopist.
  • Have given informed consent.
  • Exclusion Criteria
  • Participants will not be eligible for this study if they:
  • Have a history of inflammatory bowel disease.
  • Have a history of familial adenomatous polyposis.
  • Are under the age of 40.
  • Have had a colonoscopy within the previous three (3) years.
  • Undergoing diagnostic colonoscopy with high-risk indications including iron deficiency anemia, abnormal CT imaging, unexplained weight loss, Lynch Syndrome, blood in stool or FIT positive test.
  • Entered with poor bowel preparation (inadequate for procedure as assessed by the Investigator).
  • Use anti-platelet agents or anticoagulants that preclude the removal of polyps during the procedure.

Exclusion

    Key Trial Info

    Start Date :

    January 22 2021

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    October 31 2021

    Estimated Enrollment :

    1472 Patients enrolled

    Trial Details

    Trial ID

    NCT04754347

    Start Date

    January 22 2021

    End Date

    October 31 2021

    Last Update

    December 1 2021

    Active Locations (5)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 2 (5 locations)

    1

    Massachusetts General Hospital

    Boston, Massachusetts, United States, 02114

    2

    Boston Medical Center

    Boston, Massachusetts, United States, 02118

    3

    Mount Auburn Hospital

    Cambridge, Massachusetts, United States, 02138

    4

    MNGI Digestive Health

    Plymouth, Minnesota, United States, 55446