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We aim to investigate the incremental detection rate of polyps using AI- assisted colonoscopy compared with high-definition white-light endoscopy (HD-WLE). We will conduct a single-center randomized tandem colonoscopy trial of patients with Lynch syndrome with and without AI. Patients will undergo tandem colonoscopy, the second colonoscopy with either HD-WLE or an AI- assisted device.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Sheba Medical Center
Ramat Gan, Israel
Start Date
November 3, 2024
Primary Completion Date
May 1, 2025
Completion Date
July 1, 2025
Last Updated
March 11, 2025
100
ESTIMATED participants
artificial intelligence
DIAGNOSTIC_TEST
Lead Sponsor
Sheba Medical Center
NCT03050268
NCT06218433
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View ClinicalTrials.gov Terms and ConditionsNCT04095195