Cold Snare Piecemeal Resection vs Cold Snare Endoscopic Mucosal Resection

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Indiana University
Study ID
NCT06462521
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cold Snare Piecemeal Resection (CSPR) — PROCEDURE
    Qualifying polyps randomized to Cold Snare Piecemeal Resection (CSPR) will be removed using cold snare techniques (no electrocautery, no submucosal injection.)
  • Cold Snare Endoscopic Mucosal Resection (Cold EMR) — PROCEDURE
    Qualifying polyps randomized to Cold Snare Endoscopic Mucosal Resection (Cold EMR) will be removed using cold snare techniques (no electrocautery, with submucosal injection.)

Study Details

The study will compare the use of cold snare piecemeal resection (CSPR) vs cold endoscopic mucosal resection (Cold EMR). The study will include two cohorts: one cohort for conventional adenomas 10-19mm in size and one cohort for serrated lesions 10mm or larger.

Key Dates

Start date
Sep 6, 2024
Status verified
Sep 2025
Primary completion
Jul 31, 2027
Completion
Jul 31, 2028

Study Design

Enrollment
570 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Cold Snare Piecemeal Resection (CSPR)
    Conventional adenomas sized 10-19mm or serrated lesions 10mm or larger found during colonoscopy will be removed using CSPR technique.
  • Experimental: Cold Snare Endoscopic Mucosal Resection (Cold EMR)
    Conventional adenomas sized 10-19mm or serrated lesions 10mm or larger found during colonoscopy will be removed using Cold EMR technique.

Primary Outcome Measure

Efficacy of Resection (Central Post-Resection Biopsies) [ Time Frame: 1 day ]

Locations (1)

FacilityCityStateZIPSite coordinators
Indiana UniversityIndianapolisIndiana46202-

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Indiana University· Indianapolis, IN

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