Improving adenoma detection during colonoscopy using a balloon and AI system
Synergistic Effect of G-Eye Balloon for Behind the Folds Visualization With Artificial Intelligence Assisted Polyp Detection (Discovery System) on Adenoma Detection Rate. 'Discovery III Study'
This study is testing a new method that uses a balloon and artificial intelligence to help doctors find more polyps during colonoscopy in adults.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 194 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Radboud University Medical Center Academic / other |
| Locations | 1 site (Nijmegen, Gelderland) |
| Trial ID | NCT05220345 on ClinicalTrials.gov |
What this trial studies
This study aims to enhance the detection of colorectal polyps during colonoscopy by combining a balloon device that flattens folds in the colon with an artificial intelligence system designed for polyp detection. The research will involve an international multicenter prospective interventional cohort of 194 adult patients scheduled for various types of colonoscopy. By utilizing this combined approach, the study seeks to improve the adenoma detection rate, which is crucial for reducing the risk of interval colorectal cancer. Outcomes will be analyzed using regression modeling to account for confounding factors.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old who are scheduled for diagnostic, screening, or surveillance colonoscopy.
Not a fit: Patients with inflammatory bowel disease, known polyps or tumors, or those requiring therapeutic procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly increase the detection rates of colorectal adenomas, leading to earlier intervention and better patient outcomes.
How similar studies have performed: While the combination of AI and visualization techniques in colonoscopy is a novel approach, previous studies have shown promise in improving detection rates with AI-assisted systems.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients (\>18 years) * Referred and scheduled for diagnostic, screening (non-iFOBT based), or surveillance colonoscopy. Exclusion Criteria: * Inflammatory bowel disease (IBD) * Known polyp or tumor upon referral * Therapeutic procedure (e.g., endoscopic mucosal resection) * Prior surgical resection of any portion of the colon * American Society of Anesthesiologists score of ≥3 * Inadequately corrected anticoagulation disorder or anticoagulation medication use * inability to provide informed consent.
Where this trial is running
Nijmegen, Gelderland
- Radboud university medical center Nijmegen — Nijmegen, Gelderland, Netherlands (Recruiting)
Study contacts
- Principal investigator: Peter D Siersema, Prof — Radboud University Medical Center
- Study coordinator: Michiel JH Maas, Msc
- Email: Michiel.maas@Radboudumc.nl
- Phone: 629647175
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.