Status:
COMPLETED
Hybrid APC Assisted EMR for Large Colon Polyps
Lead Sponsor:
Milton S. Hershey Medical Center
Conditions:
Colon Polyp
Colon Adenoma
Eligibility:
All Genders
18-89 years
Phase:
NA
Brief Summary
The purpose of this study to evaluate and examine whether use of Hybrid Argon Plasma Coagulation (APC) as an adjunct to endoscopic mucosal resection (EMR) will reduce the risk of residual or recurrent...
Detailed Description
Colon Cancer is a major disease that effects more than 1 million people per year globally. Adenomatous polyps have been identified as the main precursor leading to colorectal cancer. Colon cancer scre...
Eligibility Criteria
Inclusion
- Adult patient aged ≥18 and ≤89 of any gender, ethnicity and race referred to endoscopy for resection of large colon polyps
- Patients with a ≥20mm colon non-pedunculated polyp
- Ability to give written informed consent
Exclusion
- Patients with known (biopsy proven) invasive carcinoma in a potential study polyp
- Pedunculated polyps (as defined by Paris Classification type Ip or Isp)
- Patients with ulcerated depressed lesions (as defined by Paris Classification type III)
- Patients with inflammatory bowel disease
- Patients who are receiving an emergency colonoscopy
- Poor general health (ASA class\>3)
- Patients with coagulopathy with an elevated INR ≥1.5, or platelets \<50
- Poor bowel preparation
- Target sign or perforation during initial EMR
- Need for ESD for complete resection prior to APC
- Pregnancy
Key Trial Info
Start Date :
September 28 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 27 2020
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03390907
Start Date
September 28 2018
End Date
October 27 2020
Last Update
November 8 2021
Active Locations (1)
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1
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033