The Yield of Artificial Intelligence (GI Genius) in Lynch Syndrome - A Randomized Tandem-colonoscopy Trial

April 15, 2026 updated by: Sheba Medical Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Ramat Gan, Israel, 5262000
        • Sheba medical center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: high-definition white-light endoscopy
patients undergoing first and second colonoscopy with high-definition white-light endoscopy
Active Comparator: artificial intelligence
patients undergoing first colonoscopy with high-definition white-light endoscopy and second colonoscopy with artificial intelligence
Diagnostic test: artificial intelligence
patients will undergo tandem colonoscopy with artificial intelligence

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
adenoma incremental detection rate
Time Frame: From the start of the first colonoscopy until the end of the second colonoscopy, performed on the day of enrollment (both colonoscopies performed consecutively on the same day).]
per lesion analysis, the incremental detection rate will be calculated, defined as the number of lesions detected during the second colonoscopy divided by the total number of lesions detected during first and second colonoscopy combined.
From the start of the first colonoscopy until the end of the second colonoscopy, performed on the day of enrollment (both colonoscopies performed consecutively on the same day).]

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incremental detection rate for advanced neoplasia and any polyp
Time Frame: From the start of the first colonoscopy until the end of the second colonoscopy, performed on the day of enrollment (both colonoscopies performed consecutively on the same day).]
per lesion analysis, the incremental detection rate for advance neoplasia and any polyp. In the per patient analysis, the increment in adenoma detection rate and any polyp detection rate.
From the start of the first colonoscopy until the end of the second colonoscopy, performed on the day of enrollment (both colonoscopies performed consecutively on the same day).]
The increment in adenoma detection rate / polyp detection rate
Time Frame: From the start of the first colonoscopy until the end of the second colonoscopy, performed on the day of enrollment (both colonoscopies performed consecutively on the same day).]
per lesion analysis, the incremental detection rate for advance neoplasia and any polyp. In the per patient analysis, the increment in adenoma detection rate and any polyp detection rate.
From the start of the first colonoscopy until the end of the second colonoscopy, performed on the day of enrollment (both colonoscopies performed consecutively on the same day).]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheba Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 3, 2024

Primary Completion (Actual)

November 1, 2025

Study Completion (Actual)

November 1, 2025

Study Registration Dates

First Submitted

October 21, 2024

First Submitted That Met QC Criteria

October 21, 2024

First Posted (Actual)

October 23, 2024

Study Record Updates

Last Update Posted (Actual)

April 20, 2026

Last Update Submitted That Met QC Criteria

April 15, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHEBA-20-6956-IL-CTIL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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