N/A Completed N=40 Treatment

Hybrid APC Assisted EMR for Large Colon Polyps

Colon Polyp · Colon Adenoma · Colorectal Cancer

Source: ClinicalTrials.gov NCT03390907 ↗

Enrolled (actual)

Serious AEs

7.5%

Results posted

Nov 2021

Primary outcomePrimary: Percentage of Participants Having Complete Resection — 40 Participants

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 neoplasia at 6 months. Hybrid APC is an existing FDA approved device used to assist with ablation of abnormal tissue anywhere in the GI tract.

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants Having Complete Resection	40	—
SECONDARY Measure of Within 30 Days of Procedure Adverse Events ( Post-polypectomy Bleeding and Post-polypectomy Syndrome)	3	—

Eligibility Criteria

Inclusion Criteria

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 Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03390907). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.