The Yield of Artificial Intelligence (GI Genius) in Lynch Syndrome - A Randomized Tandem-colonoscopy Trial
Launched by SHEBA MEDICAL CENTER · Oct 21, 2024
Trial Information
Current as of June 26, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
We will include patients with a known pathogenic variant (PV) / likely PV in one of the MMR genes, who are undergoing endoscopic screening and surveillance in our institute. Patients will undergo a first colonoscopy with HD-WLE, and will be randomized at 1:1 ratio to undergo a second colonoscopy with either HD-WLE or an AI- assisted device. All visualized polyps will be removed and size, histology and numbers of polyps detected on each exam will be recorded. We will evaluate the adenoma detection rate and polyp detection rate in each arm and the number of adenomas / polyps in each arm.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • patients with a known pathogenic variant in one of the mismatch repair genes, who are undergoing endoscopic screening and surveillance in our institute
- Exclusion Criteria:
- • patients \< 18 years old
- • lack of informed consent
- • concomitant inflammatory bowel disease
- • previous total colectomy
- • inadequate bowel cleansing (Boston Bowel Preparation Scale (BBPS) ≤5 or \< 2 in one of the 3 segments)
About Sheba Medical Center
Sheba Medical Center, located in Israel, is a leading academic medical institution renowned for its commitment to advancing healthcare through innovative research and clinical excellence. As a prominent clinical trial sponsor, Sheba Medical Center leverages its multidisciplinary expertise and state-of-the-art facilities to conduct rigorous clinical studies aimed at improving patient outcomes and developing novel therapeutic interventions. The center's collaborative environment fosters partnerships with global research organizations, enhancing its ability to contribute to the scientific community and drive medical advancements across various fields. With a strong focus on patient safety and ethical standards, Sheba Medical Center is dedicated to translating research findings into practical applications that benefit patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Ramat Gan, , Israel
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported