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

NCT05244278 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1596

Last updated 2025-03-05

No results posted yet for this 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.

Conditions

  • Artificial Intelligence

Interventions

DEVICE

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.

Sponsors & Collaborators

  • McGill University

    collaborator OTHER

  • University of British Columbia

    collaborator OTHER

  • Université de Sherbrooke

    collaborator OTHER

  • University of Alberta

    collaborator OTHER

  • Centre hospitalier de l'Université de Montréal (CHUM)

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-01
Primary Completion
2026-08-01
Completion
2027-01-01

Countries

  • Canada

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05244278 on ClinicalTrials.gov