Artificial Intelligence (AI) Assisted Real-time Adenoma Detection and Classification During Colonoscopies

NCT05244278 · tracked via the Priya Life Science Canada tracker

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Phase

Not applicable

Started

2023-08-01

Last updated

2026-09-21

Condition(s) studied

Artificial Intelligence

Investigational drug(s) / intervention(s)

Medtronic-GI genius (CADe system for detecting colorectal polyps)

Medtronic-GI genius (CADe system for detecting colorectal polyps): Medtronic-GI genius: AI will provide real-time feedback throughout each colonoscopy procedure and alert endoscopists to the presence of a polyp in the endoscopy field by displaying a bounding box on the same screen.

Study summary

This is a pragmatic, double-blind, randomized, controlled trial, to evaluate the effect of implementing a Computer-assisted detection (CADe) system within the routine clinical practice of Canadian healthcare institutions.

The main hypothesis of this study is that the ADR in the operating room equipped with the GI genius CADe system will be significantly higher than the ADR in the ordinary operating room.

Eligibility

Sex

ALL

Min age

45 Years

Max age

89 Years

Healthy volunteers

Inclusion Criteria: * indication of undergoing a screening, surveillance, or diagnostic colonoscopy * Age 45-89 years Exclusion Criteria: * Patients undergoing emergency colonoscopy * Patients with a known familial polyposis syndrome or a known inflammatory bowel disease

Primary outcome measure(s)

ADR — 30 days
The adenoma detection rate (ADR) is defined as the proportion of colonoscopies with at least 1 histopathologically proven adenoma or carcinoma detected.

Trial sites (1)

Facility	City	Region	Status
Centre Hospitalier Universitaire de Montréal	Montreal	Quebec	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05244278 on ClinicalTrials.gov ↗ ← All trials in Canada