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

NCT06654128 | Completed FDA Device

• 1 other identifier: SHEBA-20-6956-IL-CTIL
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lynch Syndrome

Keywords

lynch syndrome; artificial intelligence; tandem colonoscopy

Outcome Measures

Primary Outcomes (1)

• adenoma incremental detection rate

  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 Outcomes (2)

• incremental detection rate for advanced neoplasia and any polyp

  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

  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).]

Study Arms (2)

high-definition white-light endoscopy

NO INTERVENTION

patients undergoing first and second colonoscopy with high-definition white-light endoscopy

artificial intelligence

ACTIVE COMPARATOR

patients undergoing first colonoscopy with high-definition white-light endoscopy and second colonoscopy with artificial intelligence

Diagnostic Test: artificial intelligence

Interventions

artificial intelligence DIAGNOSTIC_TEST

patients will undergo tandem colonoscopy with artificial intelligence

artificial intelligence

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with a known pathogenic variant in one of the mismatch repair genes, who are undergoing endoscopic screening and surveillance in our institute

You may not qualify if:

• 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)

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Sheba Medical Center

Ramat Gan, 5262000, Israel

Location

MeSH Terms

Conditions

Colorectal Neoplasms, Hereditary Nonpolyposis

Interventions

Artificial Intelligence

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Neoplastic Syndromes, Hereditary; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; DNA Repair-Deficiency Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Algorithms; Mathematical Concepts

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: comparison of 2 groups of patients undergoing tandem colonoscopy

Study Record Dates

• First Submitted: October 21, 2024
• First Posted: October 23, 2024
• Study Start: November 3, 2024
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)