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

NCT ID: NCT05244278

Last Updated: 2025-03-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1596 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2027-01-01

Brief 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.

Detailed Description

This trial will be conducted in four centers across Canada. All patients who meet the in/exclusion criteria can be enrolled. The patient's personal medical history will be reviewed to verify patient inclusion and exclusion criteria (age, history of CRC or adenoma, comorbid conditions, anticoagulation, etc.).

Eligible patients will be randomized (1:1) stratified per center, endoscopist, sex, and age group in two arms:

1. Intervention arm: patients will be assigned to undergo colonoscopy in a room equipped with the GI genius CADe system.

2. Control arm: patients will undergo colonoscopy in a room not equipped with the GI genius CADe system.

The endoscopists performing the colonoscopies will not be involved in the development and implementation of CADe. Additionally, they won't be informed of the ongoing trial and will have the option of not using the CADe when available in the room. This design aims to mitigate operator biases that may be partly responsible for the observed difference between the CADe performance in randomized controlled trials and the CADe performance in implementation studies.

Data will be collected on case report forms (CRF), after the procedure, from the clinical files and the endoscopy reports. The data will then be deidentified and transferred to an electronic RedCap database in each institution. A research assistant will collect all information and annotations recorded on the patient's medical file during the procedure.

In the treatment group (operating room equipped with the CADe), the Medtronic-GI genius system can be used for real-time support by the endoscopists 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.

In the control group (colonoscopy performed in room without CADe system), the participating endoscopists will detect as per standard of care.

All colonoscopies (in the intervention and control groups) including polypectomy procedures will be performed at the discretion of the treating physician and per standard of care.

All polyps will be resected as per standard of care and sent to the pathology labs of the participating institutions to be evaluated for histology by board-certified pathologists. The histopathology outcomes will be collected and stored in the CRF forms to be used as a reference later.

Conditions

Artificial Intelligence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

McGill University

OTHER

Sponsor Role: collaborator

University of British Columbia

OTHER

Sponsor Role: collaborator

Université de Sherbrooke

OTHER

Sponsor Role: collaborator

University of Alberta

OTHER

Sponsor Role: collaborator

Centre hospitalier de l'Université de Montréal (CHUM)

OTHER

Sponsor Role: lead

Responsible Party

Daniel Von Renteln

Gastroenterologist, Principal Scientist, MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Centre Hospitalier Universitaire de Montréal

Montreal, Quebec, Canada

Site Status: RECRUITING

Countries

Canada

Facility Contacts

Samira Hanin

Role: primary

samira.hanin.chum@ssss.gouv.qc.ca

514-890-8000 ext. 30916

Other Identifiers

2022-10312, 21.297

Identifier Type: -

Identifier Source: org_study_id