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Search / Trial NCT06937671

Randomized Trial of Cold EMR Compared to Hybrid Cold EMR.

Launched by THE CLEVELAND CLINIC · Apr 14, 2025

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Emr Cold Emr Hybrid Emr Endoscopic Mucosal Resection

ClinConnect Summary

This clinical trial is studying a new way to remove large polyps in the colon using two different techniques: a cold method and a combination of hot and cold methods. Researchers want to see if using the hot and cold method together helps reduce the chances of the polyp coming back while also making sure there are no extra risks or complications during the procedure.

To participate in this trial, you need to be an adult, at least 18 years old, and have a polyp that is 20 mm or larger. The study is currently looking for participants, and everyone, regardless of gender, is welcome to join. If you decide to participate, you will have the polyp removed and then return for a follow-up endoscopy in 3 to 6 months to check if the polyp has returned. This trial is an important step in finding safer and more effective ways to treat large polyps.

Gender

ALL

Eligibility 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

About The Cleveland Clinic

The Cleveland Clinic is a renowned nonprofit academic medical center based in Cleveland, Ohio, recognized for its commitment to advancing healthcare through innovative research and clinical excellence. As a leading sponsor of clinical trials, the Cleveland Clinic leverages its multidisciplinary expertise and state-of-the-art facilities to conduct groundbreaking studies aimed at improving patient outcomes across a wide range of medical conditions. With a strong emphasis on patient-centered care, the institution fosters collaboration among researchers, clinicians, and patients to explore new treatments and therapies, contributing significantly to the global body of medical knowledge.

Locations

Cleveland, Ohio, United States

Weston, Florida, United States

Patients applied

0 patients applied

Trial Officials

Tilak Shah, M.D.

Principal Investigator

Cleveland Clinic Florida (Weston Hospital)

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported