Status:
COMPLETED
Evaluation of CAD-EYE/SCALE-EYE for Detection, Classification, and Measurement of Colorectal Polyps: a Prospective Study
Lead Sponsor:
Centre hospitalier de l'Université de Montréal (CHUM)
Conditions:
Colorectal Polyp
Colorectal Adenoma
Eligibility:
All Genders
45-80 years
Phase:
NA
Brief 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 purpo...
Detailed Description
Detailed Description: This study will be conducted in several phases: phase 1 will evaluate the feasibility of using CAD-eye in real-time practice, training endoscopists to work with this platform, o...
Eligibility Criteria
Inclusion
- indication of undergoing a screening, surveillance, or diagnostic colonoscopy
- Age 45-80 years
- Signed informed consent
Exclusion
- 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.
Key Trial Info
Start Date :
June 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 20 2023
Estimated Enrollment :
348 Patients enrolled
Trial Details
Trial ID
NCT05236790
Start Date
June 20 2022
End Date
June 20 2023
Last Update
October 2 2023
Active Locations (1)
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1
Centre Hospitalier Universitaire de Montréal
Montreal, Quebec, Canada