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NCT Number: NCT06937671

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.

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Key information

Conditions

Polyp of Colon Colonic Polyps Endoscopic Mucosal Resection Intestinal Polyps Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic Weston, Weston, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cold EMR

Procedure

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

Hybrid EMR

Procedure

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 outcomes

  1. Recurrence of polyps

    Time frame: 3-6 months after the procedure

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

Secondary outcomes

  1. Adverse events

    Time frame: 3-6 months after the procedure

    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

  2. Polyp recurrence rates

    Time frame: 3-6 months after EMR procedure

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

  3. Cost benefit analysis

    Time frame: 3-6 months after the procedure

    • 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.

  4. Subgroup polyp recurrence rate

    Time frame: 3-6 months after the procedure

    • Recurrence rates in the subgroup of patients with visible residual neoplasia after snare resection before utilizing forceps or cautery resection/ablation

Study contacts

Contact information is provided by the study sponsor or research team.

Akram Ahmad, M.D.

CONTACT

[email protected]

954-659-5000

Michael Nicolas, B.S.

CONTACT

[email protected]

9546596213

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 22, 2025
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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