Clinical Trial

Cold Snare Endoscopic Mucosal Resection Trial

Study acronym: LPS-II
Active, Not Recruiting
View on ClinicalTrials.gov →
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.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2019-03-05; most recent amendment 2024-06-18.
Status change: Recruiting → Active, Not Recruiting 2024-06-18
Status change: Not Yet Recruiting → Recruiting 2019-12-27
Trial Details
NCT Number NCT03865537
Lead Sponsor White River Junction Veterans Affairs Medical Center
Collaborators: Dartmouth College, Steris, Cosmo Pharmaceuticals
Conditions Colonic Polyp, Colonoscopy, Complication, Recurrence
Enrollment 990 participants
Start Date 2019-10-01
Primary Completion 2024-05-31 (estimated)
Study Completion 2027-01 (estimated)
Updated on ClinicalTrials.gov 2024-06-21