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Marginal Ulcer Healing With Low-Thermal Argon Plasma Endoscopic Treatment

RecruitingNAAges 18 Years - anyAllChristopher C. Thompson, MD, MSc
NCT06543316 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The objective of the study is to investigate the treatment of marginal ulcers with Low Thermal plasma in an endoscopic setting. By a treatment of the ulcerated areas with argon plasma with low power settings (\~ 1 W) we hypothesize that the size of the ulcers will shrink, and the healing is accelerated compared to standard of care alone. Patients will benefit from this minimally invasive approach compared to a much more invasive surgical approach that comes with higher risks and hospital stay length time. From a societal and scientific perspective, this study aims to extend the well-documented clinical benefits of plasma technology - from external wound healing to internal ulcer treatment - within an endoscopic framework. The success of this study could pave the way for broader applications of LTP in the treatment of other endoscopically accessible conditions such as peptic ulcers, duode

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📋 Eligibility rules (as published)
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.
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What it tests

  • Low Thermal Plasma (LTP) Treatment
  • Standard of Care Ulcer Treatment (typically PPI Administration)
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Where

1 site
Brigham and Women's Hospital
Boston, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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