Treatment of marginal ulcers using low-thermal argon plasma
Accelerated Marginal Ulcer Healing With Low-Thermal Argon Plasma Endoscopic Treatment
This study is testing if a new low-thermal argon plasma treatment can help heal stubborn ulcers that some people get after weight loss surgery, to see if it works better than the usual medicine.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06543316 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have undergone Roux-en-Y gastric bypass and exhibit symptoms of marginal ulcers.
Not a fit: Patients who are unable to provide informed consent or those unwilling to undergo repeated endoscopies may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve healing rates of marginal ulcers and reduce the need for invasive surgeries.
How similar studies have performed: While the application of low thermal plasma for internal ulcers is relatively novel, previous studies have shown promising results in external wound healing using similar plasma technology.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Boston, Massachusetts
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.