Cold Snare Endoscopic Mucosal Resection Trial

Summary

This study compares different approaches to endoscopic mucosal resection (EMR) of large non-pedunculated colorectal polyps (≥20mm) in a 2 x 2 randomized design. The first randomization will assign half of patients to polyp resection with electrocautery ("hot" snare EMR) and half of patient to polyp resection without electrocautery ("cold" snare EMR). The second randomization will assign half of patients to polyp removal using Eleview as the submucosal injection agent, and the other half using placebo (normal saline with methylene blue) as the submucosal injection agent.

Conditions

• Colonic Polyp
• Colonoscopy
• Complication
• Recurrence

Interventions

PROCEDURE

Cold snare EMR

Participants will have their large polyp removed without electrocautery

PROCEDURE

Hot snare EMR

Participants will have their large polyp removed with electrocautery

PROCEDURE

Eleview injection

Participants will have their polyp submucosally injected with Eleview

PROCEDURE

Placebo injection

Participants will have their polyp submucosally injected with placebo

Sponsors & Collaborators

• Dartmouth College

  collaborator OTHER

• Steris

  collaborator UNKNOWN

• Cosmo Pharmaceuticals

  collaborator UNKNOWN

• White River Junction Veterans Affairs Medical Center

  lead FED

Principal Investigators

• Heiko Pohl, MD · White River Junction VAMC, Geisel School of Medicine at Dartmouth

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-10-01

Primary Completion

2024-05-31

Completion

2027-01-31

Countries

• United States

Study Locations