Actively Recruiting
Randomized Trial Comparing Cold EMR and Hybrid Cold EMR for Large Colon Polyps
Led by The Cleveland Clinic · Updated on 2025-11-20
194
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying whether a combination of hot and cold Endoscopic Mucosal Resection (EMR) techniques can reduce the chance of polyp recurrence without increasing complications when removing large colon polyps. This randomized clinical trial compares the standard cold EMR method with a hybrid approach that adds hot avulsion and targeted treatment to the resection area. The study is sponsored by The Cleveland Clinic and focuses on adults with sizable flat or superficially raised colon polyps. Participants will be randomly assigned to one of two groups: the control group will receive the standard cold EMR treatment using cold forceps, while the intervention group will undergo the hybrid EMR treatment that includes hot avulsion of residual tissue and precise ablation of fibrotic bands in the polyp bed. The treatment happens during the initial procedure, and participants will return for a follow-up endoscopy 3 to 6 months later. During the study, participants will have a follow-up endoscopy within 3 to 6 months to check for polyp recurrence and to monitor for any adverse events. Researchers will evaluate the rate of polyp recurrence, any complications, and conduct a cost-benefit analysis based on the treatments received. Overall participation involves the initial EMR procedure and the follow-up visit for assessment, ensuring safety and measuring outcomes related to polyp recurrence.
CONDITIONS
Brief Title
Randomized Trial of Cold EMR Compared to Hybrid Cold EMR.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patient (age 18 years or older)
- Polyp size of at least 20 mm
- Flat or superficially raised polyp morphology (Paris classification 1s, 0-IIa, or 0-IIb, or a combination)
You will not qualify if you...
- Polyps with previous failed resection attempts or polyp recurrence
- Suspected deep submucosal invasion or histologically confirmed invasive adenocarcinoma
- Polyps with nodules larger than 1 to 1.5 cm unsuitable for cold snare use
- Inflammatory bowel disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 1 day
Participants undergo either Cold EMR or Hybrid Cold EMR procedures to remove large colon polyps.
1 procedure visit (in-person)
Duration - 3 to 6 months
Participants are monitored for recurrence of polyps and adverse events after the procedure.
1 to 2 follow-up visits
Trial Site Locations
Total: 2 locations
1
Cleveland Clinic Weston
Weston, Florida, United States, 33331
Actively Recruiting
2
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
Research Team
A
Akram Ahmad, M.D.
M
Michael Nicolas, B.S.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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