Evaluation of ArTificial Intelligence System (Gi-Genius) for adenoMa dEtection in Lynch Syndrome.

Last updated: March 16, 2022
Sponsor: Hospital Clinic of Barcelona
Overall Status: Active - Recruiting

Phase

N/A

Condition

Precancerous Condition

Colorectal Cancer

Colon Cancer

Treatment

N/A

Clinical Study ID

NCT04909671
Timely
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to assess if artificial intelligence aid colonoscopy colonoscopy is superior to conventional colonoscopy for the detection of adenomas during surveillance colonoscopy in patients with Lynch syndrome.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥18 years with a proven pathogenic germline variant in one of the MMR genes (MLH1,MSH2, MSH6) or Epcam deletion who are under surveillance colonoscopy.

Exclusion

Exclusion Criteria:

  • Previous history of total colectomy,
  • Concomitant inflammatory bowel disease,
  • Inability or refuse to sign the informed consent,
  • Previous colonoscopy < 12 months.
  • Inadequate bowel preparation.
  • Incomplete procedure.
  • PMS2 mutation carriers

Study Design

Total Participants: 404
Study Start date:
September 13, 2021
Estimated Completion Date:
December 01, 2023

Study Description

To compare the performance of white-light colonoscopy (HD-WLE) versus white-light + CAD (CAD) for detection of adenomas (1:1 ratio). The CAD system will include an artificial intelligence-based medical device (GI Genius, Medtronic) trained to process colonoscopy images and superimpose them, in real time, on the endoscopy display as a green box over suspected lesion. An adequate bowel preparation and minimum withdrawal time of 6 min will be required. Colonoscopies will be performed by experienced endoscopists and with high-definition scopes. Lesions will be collected, and histopathology findings used as the reference standard. The primary outcome of this trial will be the mean number of adenomas per colonoscopy (APC).

Connect with a study center

  • María Pellisé. MD. PhD.

    Barcelona, 08036
    Spain

    Active - Recruiting

  • Oswaldo ortiz

    Barcelona, 08036
    Spain

    Active - Recruiting

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