Evaluating AI-assisted colonoscopy for detecting polyps in follow-up patients
Assessing the Additional Neoplasia Yield of Computer-aided Colonoscopy in Follow-up Patients in a Screening Setting
NA · Fondazione Poliambulanza Istituto Ospedaliero · NCT06160466
This study is testing whether using AI technology during colonoscopy can help find more polyps in people aged 50 to 74 who are having follow-up procedures after previous polyp detection.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 1160 (estimated) |
| Ages | 50 Years to 74 Years |
| Sex | All |
| Sponsor | Fondazione Poliambulanza Istituto Ospedaliero (other) |
| Locations | 1 site (Brescia, Bs) |
| Trial ID | NCT06160466 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the effectiveness of Computer-Aided Detection (CADe) technology in improving the adenoma detection rate (ADR) during colonoscopy procedures. Participants aged 50 to 74, who are undergoing follow-up colonoscopy after previous polyp detection, will be randomly assigned to receive either CADe-assisted colonoscopy or conventional colonoscopy. The study will utilize the GI Genius AI software to enhance the detection of mucosal lesions in real-time, comparing the outcomes between the two groups to determine if CADe significantly increases the ADR. The trial seeks to address the issue of missed polyps during colonoscopy, which can lead to interval cancers.
Who should consider this trial
Good fit: Ideal candidates for this study are patients aged 50 to 74 who are undergoing follow-up colonoscopy after previous polyp detection.
Not a fit: Patients who are unwilling or unable to provide informed consent or those on anticoagulants that prevent polyp removal may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved detection of polyps and adenomas, potentially reducing the risk of post-colonoscopy interval cancers.
How similar studies have performed: Other studies have shown promising results with AI-assisted detection methods in colonoscopy, indicating a potential for significant advancements in this area.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged 50 to 74 undergoing colonoscopy examination following a prior colonsocopy were polyps were found (follow-up) performed in the context of a regional mass-screening program. Exclusion Criteria: * Patients unwilling or unable to give informed consent. * Patients reporting use of anti-platelet agents or anticoagulants precluding removal of polyps.
Where this trial is running
Brescia, Bs
- Fondazione Poliambulanza — Brescia, Bs, Italy (RECRUITING)
Study contacts
- Principal investigator: Cristiano Spada — Fondazione Poliambulanza
- Study coordinator: Daniele Salvi
- Email: daniele.salvi@poliambulanza.it
- Phone: 0303515373
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.
Conditions: Colonic Adenoma, Adenoma, Polyp of Colon, ADR, CADe, Follow-up