Actively Recruiting
Using AI-assisted Optical Polyp Diagnosis for Diminutive Colorectal Polyps
Led by Daniel Von Renteln · Updated on 2025-02-19
204
Participants Needed
1
Research Sites
95 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a prospective study that is the first to implement resect and discard and diagnose and leave strategies in real-time practice using stringent documentation and adjudication by 2 expert endoscopists as the gold standard. The primary aim of this study is to show the accuracy of intracolonoscopy AI-assisted optical diagnosis (CADx; autonomous or with human input) when the AI-assisted optical diagnosis made by the expert endoscopists is used as the reference standard. The specific aims are: 1. To evaluate the accuracy of intracolonoscopy AI-assisted optical polyp diagnosis (autonomous or with human input) by comparing it to the obtained optical histology diagnoses provided by two independent expert endoscopists as the reference standard. 2. To evaluate the agreement between the intracolonoscopy AI-assisted optical polyp diagnosis (autonomous or with human input) and the AI-assisted optical diagnosis performed by two independent expert endoscopists. 3. To determine whether AI-assisted optical polyp diagnosis for diminutive (1-5 mm) polyps can be implemented in routine clinical practice by demonstrating that at least 70% of the approached patients are interested in undergoing AI-assisted optical diagnosis (autonomous or with human input). 4. To evaluate the cost savings resulting from replacing pathology with AI-assisted optical diagnosis.
CONDITIONS
Official Title
Using AI-assisted Optical Polyp Diagnosis for Diminutive Colorectal Polyps
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 45-80 years
- Undergoing an outpatient colonoscopy at the Centre Hospitalier de l'Universit�e9 de Montr�e9al (CHUM)
- Signed informed consent form
You will not qualify if you...
- Inflammatory Bowel Disease
- Active colitis
- Hereditary colorectal cancer syndrome
- Coagulopathy
- American Society of Anesthesiologists (ASA) status >3
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, Canada
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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