Cold vs Hot Snare EMR for Colonic Polyps

(LPS-II Trial)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: White River Junction Veterans Affairs Medical Center

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing two methods of removing large colon growths, one using heat and one without. It also compares two different solutions to make the removal easier. The study focuses on patients with large colon polyps because these are harder to remove and have more risks. The goal is to find out which method and solution are safer and more effective.

Research Team

Heiko Pohl, MD

Principal Investigator

White River Junction VAMC, Geisel School of Medicine at Dartmouth

Eligibility Criteria

This trial is for adults with large non-pedunculated colorectal polyps (≥20mm) who are undergoing a colonoscopy and have good general health. It's not for those with poor health, inadequate bowel prep, pedunculated or ulcerated depressed lesions, suspected deep cancer invasion, pregnancy, emergency procedures, coagulopathy or inflammatory bowel disease.

Inclusion Criteria

I am 18 or older and eligible for a colonoscopy without any exclusion criteria.

I have a large colorectal polyp that is not on a stalk.

Exclusion Criteria

Inadequate bowel preparation (Boston Bowel Prep Scale, total score ≤2)

I have inflammatory bowel disease.

I have ulcerated lesions or confirmed adenocarcinoma.

Treatment Details

Interventions

• Cold snare EMR (Endoscopic Mucosal Resection)
• Eleview injection (Submucosal Injection Agent)
• Hot snare EMR (Endoscopic Mucosal Resection)
• Placebo injection (Submucosal Injection Agent)

Trial Overview The study compares two EMR techniques for removing large colorectal polyps: 'hot' snare using electrocautery and 'cold' snare without it. Additionally, it tests Eleview injection versus a placebo solution to see which is more effective in aiding the removal of these polyps.

Participant Groups

Group I: Cold snare & Eleview injection Experimental Treatment 2 Interventions

Polyp resection without electrocautery (cold snare EMR), and initial submucosal injection with Eleview

Group II: Cold Snare & Placebo injection Experimental Treatment 2 Interventions

Polyp resection without electrocautery (cold snare EMR), and initial submucosal injection with Placebo

Group III: Hot snare & Placebo injection Active Control 2 Interventions

Polyp resection with electrocautery (hot snare EMR), and initial submucosal injection with Placebo

Group IV: Hot snare & Eleview injection Active Control 2 Interventions

Polyp resection with electrocautery (hot snare EMR), and initial submucosal injection with Eleview

Who Is Running the Clinical Trial?

White River Junction Veterans Affairs Medical Center

Lead Sponsor

Trials

32

Recruited

17,900+

Steris

Collaborator

Trials

1

Recruited

990+

Cosmo Pharmaceuticals

Collaborator

Trials

1

Recruited

990+

Dartmouth College

Collaborator

Trials

93

Recruited

1,415,000+

Sian Leah Beilock

Dartmouth College

Chief Executive Officer since 2023

PhD in Cognitive Psychology and Neuroscience from Miami University

Estevan Garcia

Dartmouth College

Chief Medical Officer since 2024

MD from Stony Brook University School of Medicine

US Endoscopy

Industry Sponsor

Trials

4

Recruited

1,900+

Aries Pharmaceuticals, Inc.

Collaborator

Trials

1

Recruited

990+