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H. Pylori Eradication With Argon Plasma During Endoscopy

RecruitingNAAges 18 Years - anyAllChristopher C. Thompson, MD, MSc
NCT06529159 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 efficacy and safety of an argon plasma-based therapy - HEAPE - in treating H. pylori infections during endoscopic procedures. By filling the stomach with sodium chloride solution that is treated with APC (PAL), the Investigators hypothesize a significant reduction in H. pylori. The use of PAL instead of direct application of APC allows for a broader and more homogeneous application throughout the stomach and a faster procedure time, as the fluid bypasses the thermal effects typically associated with higher electrical power settings and focuses on the bactericidal action of PAL. It is a procedure that does not involve thermal ablation of the stomach lining. Thus, side effects should be expected to be as low as possible. Two different PAL generation modalities will be compared in this study: 1. HEAPE direct: This modality is the direct gen

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Subjects must be 18 years or older 2. Confirmed untreated H. pylori infection 3. Able to understand and sign informed consent 4. Available to return for all routine follow-up study visits 5. Patients should have upper endoscopy scheduled according to latest guidelines, e.g., as a part of their diagnostic work-up of HP positive test, regardless of their decision to participate in the study. Exclusion Criteria: 1. Patients actively undergoing H.pylori eradication therapy treatment with antibiotics or proton pump inhibitors (PPIs) two weeks prior to the HEAPE procedure. 2. Pregnancy or puerperium 3. Severe cardiopulmonary disease or a history of coronary artery disease (including myocardial infarction within the past 6 months, poorly controlled hypertension, required use of NSAIDs) 4. Lactation 5. An inability to provide informed consent 6. Any other condition which the investigator may deem as an impediment to compliance or hinder completion of the proposed study. 7. Hernias / aspiration risk
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What it tests

  • HEAPE
  • Pre-HEAPE
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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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