Comparing Cold EMR to Hybrid Cold EMR for Colon Polyps

This study is comparing two ways to remove large colon polyps (growths in the large intestine): Cold EMR and Hybrid EMR. Cold EMR uses cold tools to remove the polyp. Hybrid EMR combines Cold EMR with a hot technique to remove any remaining tissue and treat areas that might hide polyps. The main goal is to see if Hybrid EMR can reduce the chance of polyps growing back without increasing risks. You might be able to join if you are an adult with a colon polyp at least 20mm in size and have not had previous failed attempts to remove it. We are looking for 194 participants.

Study design
This is a randomized study, meaning participants are assigned to one of two treatment groups by chance. It plans to enroll 194 participants.
What's involved
Participants will undergo an Endoscopic Mucosal Resection (EMR) procedure. You will then return for a follow-up endoscopy 3-6 months after the procedure to check for polyp recurrence.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 3-6 months after the procedure to check for polyp recurrence.

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NCT06937671

Randomized Trial of Cold EMR Compared to Hybrid Cold EMR.

Recruiting
NAAges 18+InterventionalTreatment
The Cleveland Clinic
~194 participants
Updated 2026-07-29 on ClinicalTrials.gov
What's tested:Cold EMRHybrid EMR

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Recurrence of polyps
Measured over 3-6 months after the procedure
Polyp of Colon
Endoscopic Mucosal Resection
2 sites across 2 states
Florida1
Ohio1
  • Tilak Shah, M.D. · PRINCIPAL_INVESTIGATOR · Cleveland Clinic Florida (Weston Hospital)

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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
  • Recurrence of polyps3-6 months after the procedure

    Recurrence of polyps confirmed by biopsy at the site of EMR on follow-up colonoscopy