The Yield of Artificial Intelligence (GI Genius) in Lynch Syndrome - A Randomized Tandem-colonoscopy Trial
NCT ID: NCT06654128
Last Updated: 2025-03-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
100 participants
INTERVENTIONAL
2024-11-03
2025-07-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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high-definition white-light endoscopy
patients undergoing first and second colonoscopy with high-definition white-light endoscopy
No interventions assigned to this group
artificial intelligence
patients undergoing first colonoscopy with high-definition white-light endoscopy and second colonoscopy with artificial intelligence
artificial intelligence
patients will undergo tandem colonoscopy with artificial intelligence
Interventions
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artificial intelligence
patients will undergo tandem colonoscopy with artificial intelligence
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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)
18 Years
ALL
No
Sponsors
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Sheba Medical Center
OTHER_GOV
Responsible Party
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Locations
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Sheba Medical Center
Ramat Gan, , Israel
Countries
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Other Identifiers
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SHEBA-20-6956-IL-CTIL
Identifier Type: -
Identifier Source: org_study_id
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