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

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Brief Title

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

Official Title

Evaluation of ArTificial Intelligence System (Gi-Genius) for adenoMa dEtection in Lynch Syndrome. A Randomized, Parallel, Multicenter, Controlled Trial. TIMELY Study.

Brief 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.

Detailed 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).

Study Type


Primary Outcome

Mean number of adenomas per colonoscopy

Secondary Outcome

 Withdrawal time


Lynch Syndrome


Gi Genius, Medtronic

Study Arms / Comparison Groups

 CAD arm
Description:  Patients allocated to CAD arm will receive during colonoscopy withdrawal high definition white light endoscopy aided with artificial intelligence device (Gi Genius, Medtronic)


* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status


Estimated Enrollment


Start Date

February 1, 2022

Completion Date

December 1, 2023

Primary Completion Date

December 1, 2023

Eligibility Criteria

        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 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




18 Years - N/A

Accepts Healthy Volunteers



, +34 932275400, [email protected]

Location Countries


Location Countries


Administrative Informations



Organization ID


Responsible Party

Principal Investigator

Study Sponsor

Hospital Clinic of Barcelona


 European Society of Gastrointestinal Endoscopy

Study Sponsor

, , 

Verification Date

January 2022