Status:
UNKNOWN
Evaluation of ArTificial Intelligence System (Gi-Genius) for adenoMa dEtection in Lynch Syndrome.
Lead Sponsor:
Hospital Clinic of Barcelona
Collaborating Sponsors:
European Society of Gastrointestinal Endoscopy
Conditions:
Lynch Syndrome
Eligibility:
All Genders
18+ years
Phase:
NA
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 p...
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 medica...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 13 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
404 Patients enrolled
Trial Details
Trial ID
NCT04909671
Start Date
September 13 2021
End Date
December 1 2023
Last Update
March 17 2022
Active Locations (2)
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1
María Pellisé. MD. PhD.
Barcelona, Spain, 08036
2
Oswaldo ortiz
Barcelona, Spain, 08036