Artificial Intelligence (AI) Assisted Real-time Adenoma Detection and Classification During Colonoscopies
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 45
Maximum Age: 89
Healthy Volunteers: f
View:
• indication of undergoing a screening, surveillance, or diagnostic colonoscopy
• Age 45-89 years
Locations
Other Locations
Canada
Centre Hospitalier Universitaire de Montréal
RECRUITING
Montreal
Time Frame
Start Date: 2023-08-01
Estimated Completion Date: 2027-01-01
Participants
Target number of participants: 1596
Treatments
Experimental: Operating room equipped with the CADe (Medtronic-GI genius for real-time detection)
The Medtronic-GI genius (CADe) system can be used to detect polyps of all sizes. Use of CADe is left to the discretion of the treating physician performing the colonoscopy. If used CADe will provide real-time feedback throughout each colonoscopy procedure and will alert the endoscopists of the presence of a polyp in the endoscopy field by displaying a bounding box on the same screen.
No_intervention: Colonoscopy performed in room without CADe system
In the control group (standard colonoscopy), the participating endoscopists will detect and classify colorectal lesions without using any AI modules.
Related Therapeutic Areas
Sponsors
Leads: Centre hospitalier de l'Université de Montréal (CHUM)
Collaborators: McGill University, University of British Columbia, Université de Sherbrooke, University of Alberta