Evaluation of CAD-EYE/SCALE-EYE for Detection, Classification, and Measurement of Colorectal Polyps: a Prospective Study
Launched by CENTRE HOSPITALIER DE L'UNIVERSITÉ DE MONTRÉAL (CHUM) · Feb 10, 2022
Trial Information
Current as of April 30, 2025
Completed
Keywords
ClinConnect Summary
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, obtaining preliminary data on relative size measurement accuracy when using scale eye, testing feasibility of fresh polyp specimen size measurement and determining the sample size and reference standard for evaluating SCALE-EYE during the subsequent phases of the study in randomized controlled trials. Phase 2 will evaluate relative size measurement accuracy of SCALE-EYE compared to visual size e...
Gender
ALL
Eligibility criteria
- 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:
- • 1. 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.
- • 2. 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.
- • 3. For polyp detection (CADe) we will not exclude any polyp from the analysis.
About Centre Hospitalier De L'université De Montréal (Chum)
The Centre Hospitalier de l'Université de Montréal (CHUM) is a leading academic health institution in Canada, dedicated to advancing patient care through innovative research and clinical excellence. As a prominent sponsor of clinical trials, CHUM is committed to leveraging its multidisciplinary expertise and state-of-the-art facilities to facilitate groundbreaking studies that enhance medical knowledge and improve health outcomes. Collaborating with a network of healthcare professionals and researchers, CHUM fosters a rigorous research environment that prioritizes patient safety, ethical standards, and scientific integrity, positioning itself at the forefront of medical advancements.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Montréal, Quebec, Canada
Patients applied
Trial Officials
Daniel von Renteln
Principal Investigator
Centre hospitalier de l'Université de Montréal (CHUM)
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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