Actively Recruiting
Artificial Intelligence (AI) Assisted Real-time Adenoma Detection and Classification During Colonoscopies
Led by Centre hospitalier de l'Université de Montréal (CHUM) · Updated on 2025-03-05
1596
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
Sponsors
C
Centre hospitalier de l'Université de Montréal (CHUM)
Lead Sponsor
M
McGill University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the impact of using a Computer-assisted detection (CADe) system called Medtronic-GI genius during colonoscopies in Canadian healthcare centers. This randomized, double-blind study aims to see if the adenoma detection rate (ADR) is higher when the CADe technology is used compared to standard colonoscopy rooms without the system. The study includes patients aged 45 to 89 who are undergoing screening, surveillance, or diagnostic colonoscopy. Participants will be randomly assigned to two groups: one will have colonoscopies in rooms equipped with the GI genius CADe system, which can provide real-time alerts by displaying bounding boxes around polyps on the screen. The other group will have colonoscopies in standard rooms without the CADe system, relying on the endoscopist's usual detection methods. Use of the CADe system is at the discretion of the performing physician in the intervention group. All polyps found will be removed and analyzed in pathology labs as part of routine care. Throughout the study, data such as procedure details, histopathology results, and CADe usage will be collected and securely stored. Researchers will monitor outcomes including adenoma detection rates and other lesion detection measures within 30 days after colonoscopy. The study will run across four centers in Canada and continue for about three years, with regular data collection and analysis to assess the effectiveness of AI-assisted detection in routine colonoscopy practice.
CONDITIONS
Brief Title
Artificial Intelligence (AI) Assisted Real-time Adenoma Detection and Classification During Colonoscopies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Indication for screening, surveillance, or diagnostic colonoscopy
- Age 45 to 89 years
You will not qualify if you...
- Undergoing emergency colonoscopy
- Known familial polyposis syndrome
- Known inflammatory bowel disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single procedure day
Participants undergo a colonoscopy with or without the AI-assisted CADe system to detect colorectal polyps in real-time during the procedure.
1 procedure visit (in-person)
Duration - Up to 30 days
Polyps detected during colonoscopy are resected and sent for histological evaluation by board-certified pathologists to classify the lesions.
1 follow-up visit for pathology results
Trial Site Locations
Total: 1 location
1
Centre Hospitalier Universitaire de Montréal
Montreal, Quebec, Canada
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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