Recruiting

Hot & Cold EMR

Sponsor:

The Cleveland Clinic

Code:

NCT06937671

Conditions

Polyp of Colon

Endoscopic Mucosal Resection

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cold EMR

Hybrid EMR

Study Details

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 when removing large polyps.

Participants will undergo EMR and return for a follow-up endoscopy in 3-6 months to check for polyp recurrence.

Conditions

Polyp of Colon

Endoscopic Mucosal Resection

Study ID

NCT06937671

Start date

May 1, 2025

Status verified date

Jul, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

194 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Cold EMR

Control group patients that receive standard cold EMR treatment.

experimental: Hybrid cold EMR

Intervention group patients. Patients will receive hybrid EMR treatment.

Interventions

Cold EMR

Cold EMR with cold forceps (regular or jumbo forceps) removal of any visible neoplasia that cannot be ensnared.

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.

Primary outcome measure

  • Recurrence of polyps [ Time Frame: 3-6 months after the procedure ]

Central Contacts and Locations

Central contacts

Akram Ahmad, M.D.

954-659-5000ahmada5@ccf.org

Michael Nicolas, B.S.

9546596213nicolam4@ccf.org

Locations

Cleveland Clinic Weston

Recruiting

Weston, Florida, United States, 33331

Contacts

Akram Ahmad, M.D.

954-659-5000ahmada5@ccf.org

Michael Nicolas, B.S.

954-659-6213nicolam4@ccf.org

Principal Investigator:

Tilak Shah, M.D.

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Principal Investigator:

Madhusudhan Sanaka, M.D.

More Information

Sponsor

The Cleveland Clinic

Last update posted

Jul 29, 2026

Last verified

Jul, 2026

Keywords

  • EMR
  • Cold EMR
  • Hybrid EMR
  • Endoscopic mucosal resection

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The Cleveland Clinic on 2026-07-29.