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Trial Title:
Cold Snare Piecemeal Resection Vs Cold Snare Endoscopic Mucosal Resection
NCT ID:
NCT06462521
Condition:
Colon Cancer
Colon Polyp
Colon Adenoma
Serrated Polyp
Conditions: Official terms:
Adenoma
Polyps
Conditions: Keywords:
Polyp Resection
Cold Snare
Cold Endoscopic Mucosal Resection (Cold EMR)
Cold Snare Piecemeal Resection (CSPR)
Colonoscopy
Study type:
Interventional
Study phase:
N/A
Overall status:
Enrolling by invitation
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Cold Snare Piecemeal Resection (CSPR)
Description:
Qualifying polyps randomized to Cold Snare Piecemeal Resection (CSPR) will be removed
using cold snare techniques (no electrocautery, no submucosal injection.)
Arm group label:
Cold Snare Piecemeal Resection (CSPR)
Intervention type:
Procedure
Intervention name:
Cold Snare Endoscopic Mucosal Resection (Cold EMR)
Description:
Qualifying polyps randomized to Cold Snare Endoscopic Mucosal Resection (Cold EMR) will
be removed using cold snare techniques (no electrocautery, with submucosal injection.)
Arm group label:
Cold Snare Endoscopic Mucosal Resection (Cold EMR)
Summary:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- ≥ 18 years of age
- Presenting for a screening, surveillance, diagnostic, or therapeutic colonoscopy
- Found to have:
a sessile serrated lesion or hyperplastic polyp ≥ 10 mm during procedure (Serrated
Cohort) or a 10-19 mm conventional adenoma during procedure (Adenoma Cohort)
- Ability to provide informed consent
Exclusion Criteria:
- Pedunculated or semi-pedunculated polyps (as defined by Paris Classification type Ip
or Isp)
- Polyps confirmed to be anything other than sessile serrated lesion or hyperplastic
polyp on histologic diagnosis (Serrated Cohort) or
- Polyps confirmed to be anything other than conventional adenoma on histologic
diagnosis (Adenoma Cohort)
- Patients with Ulcerative Colitis or Crohn's disease
- Polyps with features suggestive of submucosal invasion
- Polyps that are not able to be removed endoscopically due to location (e.g.
extending into appendiceal orifice or diverticulum)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Indiana University
Address:
City:
Indianapolis
Zip:
46202
Country:
United States
Start date:
September 10, 2024
Completion date:
January 2026
Lead sponsor:
Agency:
Indiana University
Agency class:
Other
Collaborator:
Agency:
Rush University Medical Center
Agency class:
Other
Collaborator:
Agency:
Minneapolis Veterans Affairs Medical Center
Agency class:
U.S. Fed
Collaborator:
Agency:
John D. Dingell VA Medical Center
Agency class:
U.S. Fed
Collaborator:
Agency:
Carilion Clinic
Agency class:
Other
Collaborator:
Agency:
White River Junction Veterans Affairs Medical Center
Agency class:
U.S. Fed
Collaborator:
Agency:
The University of Kansas Medical Center
Agency class:
Other
Collaborator:
Agency:
Vancouver Coastal Health
Agency class:
Other
Collaborator:
Agency:
Université de Montréal
Agency class:
Other
Source:
Indiana University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06462521
