Health TrialsbyHealthPanel

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

ConditionArtificial Intelligence
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-89
SponsorCentre hospitalier de l'Université de Montréal (CHUM)

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

indication of undergoing a screening, surveillance, or diagnostic colonoscopy

Age 45-89 years

Disqualifiers

Patients undergoing emergency colonoscopy

Patients with a known familial polyposis syndrome or a known inflammatory bowel disease

Trial design

Design model

Parallel

Treatments tested in this trial

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

    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.

Treatment groups

1,596 Participants
are divided into 2 treatment groups
Group A: Operating room equipped with the CADe (Medtronic-GI genius for real-time detection)Experimental treatment 1 intervention
Group B: Colonoscopy performed in room without CADe systemNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

ADR

The adenoma detection rate (ADR) is defined as the proportion of colonoscopies with at least 1 histopathologically proven adenoma or carcinoma detected.

Time frame
30 days

Secondary outcomes

1

Mean number of adenomas per colonoscopy (APC)

Mean number of adenomas per colonoscopy (APC) defined as the total number of adenomas divided by the number of colonoscopies performed

Time frame
30 days
2

Sessile serrated lesions (SSL) detection rate

Sessile serrated lesions (SSL) detection rate as the proportion of patients colonoscopy in whom superior or equal to 1 sessile serrated lesion (SSL) is identified

Time frame
30 days
3

Sessile serrated lesion per Colonoscopy (SSLPC)

Sessile serrated lesion per Colonoscopy (SSLPC), defined as the total number of histologically confirmed sessile serrated lesions resected divided by the total number of colonoscopies

Time frame
30 days
4

Advanced lesion detection rate (ALDR)

Advanced lesion detection rate (ALDR), defined as the proportion of colonoscopies for which the number of histopathologically proven adenoma \>10mm was at least 1.

Time frame
30 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre hospitalier de l'Université de Montréal (CHUM)

Lead sponsor

McGill University

Collaborator

University of British Columbia

Collaborator

Université de Sherbrooke

Collaborator

University of Alberta

Collaborator

Source ClinicalTrials.gov
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