AI-assisted optical diagnosis for colorectal polyps
Using Artificial Intelligence-assisted Optical Polyp Diagnosis for Diminutive Colorectal Polyps
This study is testing whether an AI tool can accurately identify small colorectal polyps during colonoscopy, both with help from doctors and on its own, to see how well it works for patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 204 (estimated) |
| Ages | 45 Years to 80 Years |
| Sex | All |
| Sponsor | Centre hospitalier de l'Université de Montréal (CHUM) Academic / other |
| Locations | 1 site (Montreal, Quebec) |
| Trial ID | NCT06059378 on ClinicalTrials.gov |
What this trial studies
This prospective study aims to evaluate the accuracy of AI-assisted optical diagnosis for diminutive colorectal polyps during colonoscopy. It will compare the AI's diagnostic capabilities, both autonomous and with human input, against the reference standard provided by expert endoscopists. The study will involve two phases: the first 102 patients will have their diagnoses assisted by endoscopists, while subsequent patients will rely solely on autonomous AI diagnosis. Participants will be informed about the study and must provide consent to undergo the procedures.
Who should consider this trial
Good fit: Ideal candidates are adults aged 45-80 who are scheduled for an outpatient colonoscopy at the Centre Hospitalier de l'Université de Montréal.
Not a fit: Patients with inflammatory bowel disease, active colitis, hereditary colorectal cancer syndrome, coagulopathy, or those with an ASA status greater than 3 may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the accuracy of polyp diagnosis and potentially reduce unnecessary procedures for patients.
How similar studies have performed: While the use of AI in optical diagnosis is a growing field, this specific implementation of resect and discard strategies in real-time practice is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 45-80 years * Undergoing an outpatient colonoscopy at the Centre Hospitalier de l'Université de Montréal (CHUM) * Signed informed consent form Exclusion Criteria: * Inflammatory Bowel Disease; * Active colitis; * Hereditary CRC syndrome; * Coagulopathy; * American Society of Anesthesiologists (ASA) status \>3
Where this trial is running
Montreal, Quebec
- Centre Hospitalier de l'Université de Montréal — Montreal, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Daniel von Renteln, MD — Centre hospitalier de l'Université de Montréal (CHUM)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.