AI-assisted detection of adenomas during colonoscopies
Artificial Intelligence (AI) Assisted Real-time Adenoma Detection and Classification During Colonoscopies
This study is testing whether a computer system can help doctors find more adenomas during colonoscopies for people aged 45-89 in Canada.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1596 (estimated) |
| Ages | 45 Years to 89 Years |
| Sex | All |
| Sponsor | Centre hospitalier de l'Université de Montréal (CHUM) Academic / other |
| Locations | 1 site (Montreal, Quebec) |
| Trial ID | NCT05244278 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the effectiveness of a Computer-assisted detection (CADe) system in improving adenoma detection rates during colonoscopies in Canadian healthcare institutions. It is a double-blind, randomized, controlled trial involving four centers across Canada. Patients aged 45-89 who are scheduled for screening, surveillance, or diagnostic colonoscopy will be randomly assigned to either an intervention group using the GI genius CADe system or a control group without it. The study aims to minimize operator bias by keeping endoscopists unaware of the trial's specifics.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 45-89 scheduled for a screening, surveillance, or diagnostic colonoscopy.
Not a fit: Patients undergoing emergency colonoscopy or those with known familial polyposis syndrome or inflammatory bowel disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly enhance the detection of adenomas during colonoscopies, leading to better patient outcomes.
How similar studies have performed: Other studies have shown promising results with similar AI-assisted detection approaches, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * indication of undergoing a screening, surveillance, or diagnostic colonoscopy * Age 45-89 years Exclusion Criteria: * Patients undergoing emergency colonoscopy * Patients with a known familial polyposis syndrome or a known inflammatory bowel disease
Where this trial is running
Montreal, Quebec
- Centre Hospitalier Universitaire de Montréal — Montreal, Quebec, Canada (Recruiting)
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.