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Trial Title:
The Yield of Artificial Intelligence (GI Genius) in Lynch Syndrome - a Randomized Tandem-colonoscopy Trial
NCT ID:
NCT06654128
Condition:
Lynch Syndrome
Conditions: Official terms:
Colorectal Neoplasms, Hereditary Nonpolyposis
Syndrome
Conditions: Keywords:
lynch syndrome
artificial intelligence
tandem colonoscopy
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
comparison of 2 groups of patients undergoing tandem colonoscopy
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
artificial intelligence
Description:
patients will undergo tandem colonoscopy with artificial intelligence
Arm group label:
artificial intelligence
Summary:
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.
Detailed description:
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.
Criteria for 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)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
November 1, 2024
Completion date:
July 1, 2025
Lead sponsor:
Agency:
Sheba Medical Center
Agency class:
Other
Source:
Sheba Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06654128
