Eradicating H. Pylori with Argon Plasma During Endoscopy

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 efficacy and safety of a novel argon plasma-based therapy, known as HEAPE, for treating H. pylori infections during endoscopic procedures. The approach involves filling the stomach with a sodium chloride solution treated with plasma activated liquid (PAL), which aims to reduce H. pylori without the thermal damage associated with traditional methods. Two different modalities of PAL generation will be compared to assess their effectiveness. The study targets patients with confirmed untreated H. pylori infections undergoing upper endoscopy.

Why it matters

Who can join: the full rules

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

Where it's running

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

Study contacts

• Principal investigator: Christopher C Thompson, MD — Brigham and Women's Hospital
• Study coordinator: Michele 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.