Real-time AI system to measure colorectal polyp size during colonoscopy
A Prospective Study to Evaluate the Performance of a Real-time System in the Estimation of Colorectal Polyp Size
This will test a real-time AI tool called EndoAIM that automatically measures polyp diameter during colonoscopies in adults having screening, surveillance, or symptom evaluation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 278 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Locations | 1 site (Shatin) |
| Trial ID | NCT06957015 on ClinicalTrials.gov |
What this trial studies
This prospective study will use EndoAIM, an artificial intelligence tool that automatically estimates polyp diameter in real time during colonoscopy. Measurements from EndoAIM will be recorded during routine colonoscopies at Prince of Wales Hospital and compared with endoscopists' visual estimates and available reference measurements (for example calibrated instruments or resected specimen measurements) to characterize accuracy, particularly around the 10 mm threshold. The study enrolls adults aged 18 and older undergoing screening, surveillance, or symptom investigation who can provide informed consent and excludes those with contraindications to colonoscopy or polyp resection and those with severe comorbidities (ASA grade 4+). Preclinical data for EndoAIM are promising and the trial aims to establish its real-time performance and potential to reduce size misclassification observed with visual estimation.
Who should consider this trial
Good fit: Adults aged 18 or older undergoing colonoscopy for screening, surveillance, or symptoms who can give informed consent and have no contraindication to colonoscopy or polyp resection.
Not a fit: Patients who cannot undergo colonoscopy or polyp resection (for example due to intestinal obstruction, active bleeding, uninterrupted anticoagulation, or ASA grade 4+) would not benefit from participating.
Why it matters
Potential benefit: If successful, the tool could make polyp size measurements more accurate in routine colonoscopy, reducing under- or over-surveillance and helping choose appropriate resection approaches.
How similar studies have performed: Other AI-based polyp sizing systems have shown promising accuracy in video-based studies, but real-time clinical validation is limited and EndoAIM's encouraging preclinical results require prospective confirmation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Subjects are eligible if: 1. They have received colonoscopy for screening, surveillance or symptom investigation; 2. Aged 18 years older or above; 3. Written informed consent obtained. Exclusion Criteria: Subjects are excluded if they have: 1. Contraindication to colonoscopy (e.g. intestinal obstruction or perforation) 2. Contraindication or conditions precluding polyp resection (e.g. active gastrointestinal bleeding, uninterrupted anticoagulation or dual antiplatelets) 3. Advanced comorbid conditions (defined as American Society of Anesthesiologists grade 4 or above)
Where this trial is running
Shatin
- Prince of Wales Hospital — Shatin, Hong Kong (Recruiting)
Study contacts
- Principal investigator: Louis HS Lau, FRCP — Chinese University of Hong Kong
- Study coordinator: Louis HS Lau, FRCP
- Email: louishslau@cuhk.edu.hk
- Phone: 26370428
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.