NCT06937671NARecruiting
Randomized Trial of Cold EMR Compared to Hybrid Cold EMR.
The Cleveland Clinic
Start Date
5/1/2025
Completion Date
12/1/2026
Summary
The goal of this randomized clinical trial is to learn if a combination of hot and cold EMR technique is associated with a lower risk of polyp recurrence without increasing the risk of complication when removing large polyps. Participants will undergo EMR and return for a follow-up endoscopy in 3-6 months to check for polyp recurrence.
Eligibility Criteria
Age Range: 18 years to No maximum
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
Interventions
PROCEDURE
Cold EMR
PROCEDURE
Hybrid EMR
Conditions
Polyp of ColonEndoscopic Mucosal Resection
Locations
Cleveland Clinic Weston
Weston, Florida 33331
United States
Cleveland Clinic
Cleveland, Ohio 44195
United States