NCT05244278

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,596

participants targeted

Target at P75+ for not_applicable

Timeline
7mo left

Started Aug 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress84%
Aug 2023Jan 2027

First Submitted

Initial submission to the registry

February 8, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 17, 2022

Completed
1.5 years until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

March 5, 2025

Status Verified

February 1, 2025

Enrollment Period

3 years

First QC Date

February 8, 2022

Last Update Submit

February 28, 2025

Conditions

Artificial Intelligence

Keywords

Polyp detectionAdenoma detectionAdenoma per colonoscopySessile serrated lesion detection rateSessile serrated lesion per colonoscopy

Outcome Measures

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.

    30 days

Secondary Outcomes (7)

  • Mean number of adenomas per colonoscopy (APC)

    30 days

  • Sessile serrated lesions (SSL) detection rate

    30 days

  • Sessile serrated lesion per Colonoscopy (SSLPC)

    30 days

  • Advanced lesion detection rate (ALDR)

    30 days

  • Proximal ADR

    30 days

  • +2 more secondary outcomes

Study Arms (2)

Operating room equipped with the CADe (Medtronic-GI genius for real-time detection)

EXPERIMENTAL

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.

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

Colonoscopy performed in room without CADe system

NO INTERVENTION

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)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.

Operating room equipped with the CADe (Medtronic-GI genius for real-time detection)

Eligibility Criteria

Age45 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire de Montréal

Montreal, Quebec, Canada

RECRUITING

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
Allocation will be concealed; the patients and the participating endoscopists will not be informed of the treatment group.
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: pragmatic double-blinded, randomized, multi-endoscopist, multicenter
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Gastroenterologist, Principal Scientist, MD, PhD

Study Record Dates

First Submitted

February 8, 2022

First Posted

February 17, 2022

Study Start

August 1, 2023

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

January 1, 2027

Last Updated

March 5, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)