Actively Recruiting
H. Pylori Eradication With Argon Plasma During Endoscopy HEAPE
Led by Christopher C. Thompson, MD, MSc · Updated on 2026-03-02
20
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
C
Christopher C. Thompson, MD, MSc
Lead Sponsor
E
Erbe Elektromedizin GmbH
Collaborating Sponsor
AI-Summary
What this Trial Is About
Helicobacter pylori H. pylori infection affects about half the worlds population and is a major cause of ulcers and gastric cancer. Current antibiotic treatments are effective in about 80 of cases, but increasing antibiotic resistance makes new treatments necessary. This study evaluates a new argon plasma-based therapy called HEAPE to reduce or eradicate H. pylori bacteria during endoscopic procedures, aiming to offer an alternative approach to antibiotic therapy. The study compares two ways of delivering plasma activated liquid PAL treatment HEAPE direct, where the stomach is filled with sodium chloride solution that is treated with argon plasma inside the stomach, and Pre-HEAPE, where the sodium chloride solution is treated outside the body and then administered into the stomach via endoscope. Both methods use the antibacterial properties of PAL without causing thermal damage to the stomach lining. After the procedure, patients receive standard antibiotic treatment and follow-up testing. Participants will undergo a urea breath test before and two hours after the PAL treatment to measure immediate changes in H. pylori levels and again four weeks later to assess eradication. Researchers will monitor symptoms, quality of life, and any side effects during and after the procedure. The study is randomized and designed to assess safety, tolerability, and proof of concept for PAL as a non-thermal antibacterial treatment for H. pylori infection.
CONDITIONS
Brief Title
H. Pylori Eradication With Argon Plasma During Endoscopy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 as part of their diagnostic work-up for H. pylori positive test
You will not qualify if you...
- Patients undergoing H. pylori eradication therapy with antibiotics or proton pump inhibitors within two weeks before the HEAPE procedure
- Pregnancy or puerperium
- Severe cardiopulmonary disease or history of coronary artery disease including recent myocardial infarction within 6 months
- Lactation
- Inability to provide informed consent
- Any condition that may hinder compliance or study completion as judged by investigator
- Presence of hernias or aspiration risk
Research Team
M
Michele Ryan, MS
S
Samantha Geltz
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