Status:
RECRUITING
H. Pylori Eradication With Argon Plasma During Endoscopy
Lead Sponsor:
Christopher C. Thompson, MD, MSc
Collaborating Sponsors:
Erbe Elektromedizin GmbH
Conditions:
Helicobacter Pylori Infection
Helicobacter Pylori
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 wi...
Detailed Description
Helicobacter pylori (H. pylori) is a prevalent bacterial infection that colonizes the gastric mucosa, affecting approximately 50% of the global population. Classified by the WHO as a class 1 carcinoge...
Eligibility Criteria
Inclusion
- Subjects must be 18 years or older
- Confirmed untreated H. pylori infection
- Able to understand and sign informed consent
- Available to return for all routine follow-up study visits
- 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
- Patients actively undergoing H.pylori eradication therapy treatment with antibiotics or proton pump inhibitors (PPIs) two weeks prior to the HEAPE procedure.
- Pregnancy or puerperium
- 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)
- Lactation
- An inability to provide informed consent
- Any other condition which the investigator may deem as an impediment to compliance or hinder completion of the proposed study.
- Hernias / aspiration risk
Key Trial Info
Start Date :
July 8 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06529159
Start Date
July 8 2025
End Date
December 1 2026
Last Update
August 5 2025
Active Locations (1)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115