Recruiting

GI Genius

Sponsor:

Centre hospitalier de l'Université de Montréal (CHUM)

Code:

NCT05244278

Conditions

Artificial Intelligence

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

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.

Conditions

Artificial Intelligence

Study ID

NCT05244278

Start date

Aug 1, 2023

Status verified date

Feb, 2025

Completion date

Jan 1, 2027

Anticipated

Primary completion date

Aug 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

1596 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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.

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.

Primary outcome measure

  • ADR [ Time Frame: 30 days ]

Central Contacts and Locations

Locations

Centre Hospitalier Universitaire de Montréal

Recruiting

Montréal, Quebec, Canada

Contacts

Samira Hanin

514-890-8000samira.hanin.chum@ssss.gouv.qc.ca

Principal Investigator:

Daniel von Renteln, MD, PhD

More Information

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Last update posted

Mar 5, 2025

Last verified

Feb, 2025

Keywords

  • Polyp detection
  • Adenoma detection
  • Adenoma per colonoscopy
  • Sessile serrated lesion detection rate
  • Sessile serrated lesion per colonoscopy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Centre hospitalier de l'Université de Montréal (CHUM) on 2025-03-05.