Treatment of marginal ulcers using low-thermal argon plasma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effectiveness of low thermal plasma endoscopic treatment for healing marginal ulcers that occur after Roux-en-Y gastric bypass surgery. By applying argon plasma at low power settings, the researchers aim to shrink the size of these ulcers and accelerate healing compared to standard care, which typically involves prolonged use of proton pump inhibitors. The study seeks to provide a minimally invasive alternative to more invasive surgical interventions, potentially improving patient outcomes and reducing hospital stays. The research also aims to explore the broader applications of plasma technology in treating other endoscopically accessible ulcers.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Subjects aged 18 years and above, inclusive of both males and females.
* Patients with a history of Roux-en-Y gastric bypass (RYGB) presenting symptoms indicative of marginal ulcers (MUs) such as abdominal pain, nausea, vomiting, gastrointestinal bleeding, or dysphagia.
* Subjects must be scheduled for an EGD for the evaluation of these symptoms.
* Marginal ulcers confirmed during the initial EGD.
* Willingness to adhere to the SOC treatment, which includes PPIs.
* Subjects able to tolerate repeated endoscopic procedures.
* Capacity for providing informed consent and understanding of study requirements.
* Willingness and ability to attend required follow-up assessments at 4 weeks (+/- 1 week) and 8 weeks (+/- 2 weeks).

Exclusion Criteria:

* Inability to provide informed consent.
* Unwillingness to undergo repeated endoscopies.
* Inability or unwillingness to comply with the SOC.
* Current use of systemic antibiotics.
* Any condition deemed by the investigator to compromise the safety of undergoing an endoscopic procedure.
* Pregnancy, lactation, or absence of reliable contraception in women of childbearing potential.
* Current enrollment in another investigational trial with potential to interfere with this study's endpoint analyses.

Where it's running

• Brigham and Women's Hospital
  Boston, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Christopher C. Thompson, MD, MSc — Brigham and Womens Hospital
• Study coordinator: Michele B Ryan, MS
• Email: mryan@bwh.harvard.edu
• Phone: 617-525-8266

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.