Evaluating the long-term effectiveness of AI-assisted colonoscopy on adenoma recurrence
Longterm Effectiveness of Artificial Intelligence-assisted Colonoscopy on Adenoma Recurrence - a Prospective Longitudinal Follow-up of Randomized Controlled Trial
This study is testing if using AI during colonoscopy can help prevent the return of adenomas in high-risk patients over three years compared to regular colonoscopy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 775 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT06251700 on ClinicalTrials.gov |
What this trial studies
This study investigates the long-term effectiveness of AI-assisted colonoscopy in reducing adenoma recurrence compared to standard colonoscopy. Following a previous randomized controlled trial, participants who received AI-assisted colonoscopy will be monitored for adenoma recurrence over a three-year period. The goal is to determine if the increased detection of adenomas can lead to better long-term outcomes and potentially extend surveillance intervals for high-risk patients. This real-world, prospective study aims to provide insights into the impact of AI technology on colonoscopy outcomes.
Who should consider this trial
Good fit: Ideal candidates are individuals who participated in the ENDOAID-TRAIN study and are willing to undergo a follow-up surveillance colonoscopy at year 3.
Not a fit: Patients with advanced comorbidities, a history of colorectal cancer, or those who have undergone colectomy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved long-term outcomes for patients undergoing colonoscopy by reducing the incidence of adenoma recurrence.
How similar studies have performed: Previous studies have shown promising results with AI-assisted colonoscopy, indicating potential benefits, but this specific long-term effectiveness assessment is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Subjects are eligible if: (i) They underwent randomization to receive colonoscopy with/without CADe in ENDOAID-TRAIN study \[NCT04838951\]; (ii) They are fit and willing to undergo surveillance colonoscopy at year 3; (iii) Written informed consent obtained. Exclusion Criteria: Subjects will be excluded from the study if they have any of the followings: (i) Incomplete colonoscopy during index procedure; (ii) Known residual colorectal neoplasia not removed (except hyperplastic polyps); (iii) Underwent unscheduled interval colonoscopy before year 3; (iv) Contraindications to surveillance colonoscopy at year 3; (v) Advanced comorbid (American Society of Anesthesiologists grade 4 or above); (vi) History of CRC, hereditary polyposis syndrome or inflammatory bowel disease; (vii) History of colectomy at any time point.
Where this trial is running
Hong Kong
- Prince of Wales Hospital — Hong Kong, Hong Kong (Recruiting)
Study contacts
- Study coordinator: Felix Sia
- Email: felixsia@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.