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AI-Assisted Optical Diagnosis (CADx) for Diminutive Colorectal Polyps

NCT07738484 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 840

Last updated 2026-07-31

No results posted yet for this study

Summary

This study evaluates whether an artificial intelligence system (GI Genius, Medtronic), already approved by Health Canada, can help doctors accurately identify, in real time during colonoscopy, which small colorectal polyps (5 mm or less) need to be monitored (adenomas) versus those that do not (for example, hyperplastic polyps). For each small polyp found, the endoscopist will first record a diagnosis without the help of the artificial intelligence system, then activate the system and record a second diagnosis after seeing its assessment. Both diagnoses will be compared to the final result from standard pathology testing, which remains the reference standard. This is an observational diagnostic accuracy study: it does not change any clinical care. All polyps continue to be removed and sent for pathology analysis as usual, whether or not the artificial intelligence system agrees with the doctor. The study will take place during colonoscopies already scheduled for standard clinical reasons (screening, surveillance, or diagnostic work-up), with no additional visits, blood draws, imaging, or sedation. Approximately 840 participants will be enrolled across three Canadian centres (Santé Québec - CHUM, McGill University Health Centre, and St. Paul's Hospital, Vancouver). The goal is to determine whether this AI-assisted approach helps doctors reach the internationally recognized performance thresholds (at least 80% sensitivity and 80% specificity) needed to support clinical adoption of real-time optical diagnosis, which could eventually reduce unnecessary pathology testing.

Conditions

  • Colorectal Polyps
  • Colorectal Adenoma
  • Diminutive Colorectal Polyp

Interventions

DEVICE

GI Genius CADx module (Medtronic)

Computer-aided diagnosis (CADx) device recently approved by Health Canada, used to provide real-time optical characterization of diminutive colorectal polyps (≤5 mm) during colonoscopy. For each diminutive polyp detected, the endoscopist first records a CADx-unassisted optical diagnosis (electronically locked before device activation), then activates the GI Genius CADx module, which displays a device-provided characterization. The endoscopist then records a final CADx-assisted optical diagnosis, which may agree or disagree with the device output. The study evaluates the CADx-assisted optical-diagnosis strategy (endoscopist + device combined) rather than autonomous or standalone CADx performance.

Sponsors & Collaborators

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

    lead OTHER

Eligibility

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

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2029-08-31
Completion
2029-08-31
FDA Device
Yes

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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 NCT07738484 on ClinicalTrials.gov