RecruitingNot ApplicableNCT05244278

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


Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Enrollment

1,596 participants

Start Date

Aug 1, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 45 YearsMax Age: 89 Years

Inclusion Criteria2

  • indication of undergoing a screening, surveillance, or diagnostic colonoscopy
  • Age 45-89 years

Exclusion Criteria2

  • Patients undergoing emergency colonoscopy
  • Patients with a known familial polyposis syndrome or a known inflammatory bowel disease

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Interventions

DEVICEMedtronic-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.


Locations(1)

Centre Hospitalier Universitaire de Montréal

Montreal, Quebec, Canada

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NCT05244278


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