Performance Evaluation of CAD-EYE and SCALE-EYE for Detection, Classification, and Measurement of Colorectal Polyps: a Prospective Study

  • STATUS
    Recruiting
  • days left to enroll
    73
  • participants needed
    348
  • sponsor
    Centre hospitalier de l'Université de Montréal (CHUM)
Updated on 4 October 2022

Summary

The investigators hypothesize that the clinical implementation of an AI system is an optimal tool to monitor, audit and improve the detection and classification of polyps during colonoscopy. The purpose of this prospective clinical cohort study is to evaluate the performance of the SCALE-EYE virtual scale for measuring polyp size when used during live colonoscopies. The investigators also wish to evaluate CAD-eye for detection and classification of polyp histology. It is hypothesized that CAD-eye and SCALE-EYE can function in real-time practice with high accuracy.

Details
Condition Artificial Intelligence
Treatment Detection and classification and size measurement of polyp by Artificial Intelligence (Cad eye) and the Scale Eye
Clinical Study IdentifierNCT05236790
SponsorCentre hospitalier de l'Université de Montréal (CHUM)
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

indication of undergoing a screening, surveillance, or diagnostic colonoscopy
Age 45-80 years
Signed informed consent

Exclusion Criteria

Known inflammatory bowel disease (IBD)
Active Colitis
Poor general health, defined as an American Society of Anesthesiologists (ASA) physical status class >3
Coagulopathy
Familial polyposis syndrome
Emergency colonoscopies
Poor bowel preparation score defined as the total Boston bowel preparation score <6 and the right-segment score <2
For per-polyp analysis
For optical diagnosis (CADx) we will exclude all polyps >5mm. We will also exclude sessile serrated polyps and traditional serrated adenomas from the analysis as CADx can only differentiate between adenomas and hyperplastic polyps
For polyp size measurement (SCALE-EYE), we will exclude all polyps resected in several pieces (piecemeal resection), or specimens damaged (e.g., fractured) during the suction and retrieval process, submillimeter polyps too small for measurement after resection. Polyps after the 5th resected polyp in a single piece will be excluded to reduce the time associated with the procedure
For polyp detection (CADe) we will not exclude any polyp from the analysis
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