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 range

18 Years – 89 Years

Sex

ALL

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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