Comparing cold and hybrid techniques for removing large colon polyps
Randomized Trial of Cold EMR Compared to Hybrid Cold EMR.
This study is testing if a new way of removing large colon polyps that combines two techniques can lower the chances of the polyps coming back and reduce complications for adults with certain types of polyps.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 194 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Cleveland Clinic Academic / other |
| Locations | 2 sites (Weston, Florida and 1 other locations) |
| Trial ID | NCT06937671 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to determine whether a hybrid approach combining cold endoscopic mucosal resection (EMR) with traditional cold EMR can reduce the risk of polyp recurrence while minimizing complications in patients with large colon polyps. Participants will undergo EMR and will return for a follow-up endoscopy in 3-6 months to assess for any recurrence of polyps. The study focuses on adults with specific polyp characteristics, ensuring a targeted approach to treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 years or older with large colon polyps measuring at least 20 mm and specific morphological characteristics.
Not a fit: Patients with previous failed resection attempts, suspected deep submucosal invasion, or inflammatory bowel disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved outcomes for patients by reducing the likelihood of polyp recurrence after removal.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in improving outcomes with EMR techniques.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patient (age 18 years or older) * Polyp size of at least 20 mm * \- Morphology: Flat or superficially raised polyp morphology (i.e., Paris classification 1s, 0-IIa or 0-IIb, or a combination of the above) Exclusion Criteria: * Polyps with previous failed resection attempts or polyp recurrence * Suspected deep submucosal invasion on endoscopic assessment of surface mucosal pit pattern (Kudo V or NICE 3 pattern) or histologically confirmed malignancy (invasive adenocarcinoma) * Polyps with nodules too large (\>1-1.5cm) for the use of a cold snare * Inflammatory bowel disease
Where this trial is running
Weston, Florida and 1 other locations
- Cleveland Clinic Weston — Weston, Florida, United States (Recruiting)
- Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Tilak Shah, M.D. — Cleveland Clinic Florida (Weston Hospital)
- Study coordinator: Akram Ahmad, M.D.
- Email: ahmada5@ccf.org
- Phone: 954-659-5000
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.