CompletedNot Applicable

Hybrid APC Assisted EMR for Large Colon Polyps

United States40 participantsStarted 2018-09-28

Plain-language 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.

Who can participate

Age range18 Years – 89 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Percentage of Participants Having Complete Resection

Timeframe: 6 months post initial procedure

Trial details

NCT IDNCT03390907

SponsorMilton S. Hershey Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-10-27

Results submitted2021-10-06

View on ClinicalTrials.gov More Colon Polyp trials