Status:
RECRUITING
Randomized Trial of Cold EMR Compared to Hybrid Cold EMR.
Lead Sponsor:
The Cleveland Clinic
Conditions:
Polyp of Colon
Endoscopic Mucosal Resection
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 wh...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
194 Patients enrolled
Trial Details
Trial ID
NCT06937671
Start Date
May 1 2025
End Date
December 1 2026
Last Update
November 20 2025
Active Locations (2)
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1
Cleveland Clinic Weston
Weston, Florida, United States, 33331
2
Cleveland Clinic
Cleveland, Ohio, United States, 44195