Randomized Trial of Cold EMR Compared to Hybrid Cold EMR.

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.

Study Overview

• Status: Recruiting
• Conditions: Polyp of Colon; Endoscopic Mucosal Resection
• Intervention / Treatment: Procedure: Cold EMR; Procedure: Hybrid EMR

• Study Type: Interventional
• Enrollment (Estimated): 194
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Akram Ahmad, M.D.; Phone Number: 954-659-5000; Email: ahmada5@ccf.org
• Study Contact Backup: Name: Michael Nicolas, B.S.; Phone Number: 9546596213; Email: nicolam4@ccf.org

Study Locations

• United States
  • Florida
    • Weston, Florida, United States, 33331
      • Recruiting
      • Cleveland Clinic Weston
      • Contact: Akram Ahmad, M.D.; Phone Number: 954-659-5000; Email: ahmada5@ccf.org
      • Contact: Michael Nicolas, B.S.; Phone Number: 954-659-6213; Email: nicolam4@ccf.org
      • Principal Investigator: Tilak Shah, M.D.
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Recruiting
      • Cleveland Clinic
      • Contact: Madhusudhan Sanaka, M.D.
      • Principal Investigator: Madhusudhan Sanaka, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cold EMR; Control group patients that receive standard cold EMR treatment.	Procedure: Cold EMR; Cold EMR with cold forceps (regular or jumbo forceps) removal of any visible neoplasia that cannot be ensnared.
Experimental: Hybrid cold EMR; Intervention group patients. Patients will receive hybrid EMR treatment.	Procedure: Hybrid EMR; Cold EMR with hot avulsion of any visible residual neoplasia within the resection bed, in addition to precise APC of the fibrotic bands that may harbor invisible neoplasia within the resection bed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence of polyps	Recurrence of polyps confirmed by biopsy at the site of EMR on follow-up colonoscopy	3-6 months after the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	Composite of clinically important adverse events: (1) Perforation requiring hospitalization or surgery (2) Bleeding associated with at least 2-gram Hb drop or hospitalization or Intervention (3) Post-polypectomy syndrome requiring hospital admission	3-6 months after the procedure
Polyp recurrence rates	Recurrence of polyps confirmed by biopsy at the site of EMR on follow-up colonoscopy	3-6 months after EMR procedure
Cost benefit analysis	- Cost-benefit analysis includes the costs of additional hospitalizations related to post-procedure complications and the cost of additional colonoscopies required to follow up treatment of recurrence. Costs will be calculated from a Medicare perspective.	3-6 months after the procedure
Subgroup polyp recurrence rate	- Recurrence rates in the subgroup of patients with visible residual neoplasia after snare resection before utilizing forceps or cautery resection/ablation	3-6 months after the procedure

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Investigators: Principal Investigator: Tilak Shah, M.D., Cleveland Clinic Florida (Weston Hospital)

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: April 11, 2025
• First Submitted That Met QC Criteria: April 14, 2025
• First Posted (Actual): April 22, 2025

Study Record Updates

• Last Update Posted (Actual): November 20, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Endoscopic mucosal resection; EMR; Cold EMR; Hybrid EMR
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Polyps; Intestinal Polyps; Pathological Conditions, Signs and Symptoms; Colonic Polyps
• Other Study ID Numbers: 25-126

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No