Management of Helicobacter pylori infection--the Maastricht IV/ Florence Consensus Report.
Peter Malfertheiner, Francis Megraud, Colm A O'Morain...
https://pubmed.ncbi.nlm.nih.gov/22491499/Actively Recruiting
Led by Christopher C. Thompson, MD, MSc · Updated on 2026-03-02
20
Participants Needed
1
Research Sites
52 weeks
Total Duration
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
H. Pylori Eradication With Argon Plasma During Endoscopy
M
Michele Ryan, MS
S
Samantha Geltz
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Christopher C. Thompson, MD, MSc
Lead Sponsor
Erbe Elektromedizin GmbH
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Direct Plasma Activation In Situ | Plasma Activation Outside Body |
|---|---|---|
| What it is | A procedure where sodium chloride solution is filled in the stomach and activated on site with argon plasma during endoscopy to create an antibacterial solution. | A procedure where plasma-activated sodium chloride solution is prepared before endoscopy and delivered into the stomach via endoscope. |
| Role in trial | Primary investigational arm to assess whether direct in situ plasma activation within the stomach improves H. pylori reduction versus externally activated saline. | Active trial comparator; evaluates effectiveness of externally activated saline for H. pylori reduction. |
| Primary use | Intended for rapid reduction of H. pylori load in the stomach as part of endoscopic treatment. | Designed to reduce H. pylori load in the stomach using plasma-activated saline prepared outside the body. |
| How it is given or performed | Sodium chloride solution is infused into the stomach then activated directly by argon plasma through the endoscope during the procedure. | Plasma activation occurs outside the patient, then the prepared antibacterial saline is administered to the stomach via endoscope using a syringe. |
| Evidence status | Ongoing randomized trial with no posted results. Previous laboratory evidence supports plasma-activated saline's antibacterial effect, but clinical efficacy in H. pylori not yet established. | Ongoing randomized trial with no posted results. Laboratory evidence supports plasma activation as bactericidal, but clinical impact in H. pylori eradication remains under study. |
| Important limitations | Being evaluated in a small clinical trial without published efficacy or safety results. Clinical effectiveness and duration of antibacterial effect in treating H. pylori infection are unknown. Procedure requires endoscopic access. | Clinical outcomes not yet reported; antibacterial efficacy and safety in H. pylori infection are unknown. Like HEAPE direct, procedure depends on endoscopic delivery. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single treatment visit
Participants receive treatment with either direct generation of plasma activated liquid in the stomach or administration of plasma activated sodium chloride solution into the stomach through an endoscope.
1 treatment visit (in-person)
Duration - 4 weeks
Participants are monitored for H. pylori eradication, symptom changes, and adverse events after treatment.
Visits at 2 hours and 4 weeks post-treatment (in-person)
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Have more questions? Get in touch with our team for quick support
Peter Malfertheiner, Francis Megraud, Colm A O'Morain...
https://pubmed.ncbi.nlm.nih.gov/22491499/A Eickhoff, R Jakobs, D Schilling...
https://pubmed.ncbi.nlm.nih.gov/17611919/Shailja Shah, Elizabeth Hubscher, Corey Pelletier...
https://pubmed.ncbi.nlm.nih.gov/35315732/Daniel M Mrochen, Lea Miebach, Henry Skowski...
https://pubmed.ncbi.nlm.nih.gov/36041652/Francis Mégraud, David Y Graham, Colin W Howden...
https://pubmed.ncbi.nlm.nih.gov/36191284/K E Grund, T Straub, G Farin
https://pubmed.ncbi.nlm.nih.gov/11030635/Liyun Wang, Chuankai Xia, Yajun Guo...
https://pubmed.ncbi.nlm.nih.gov/31989838/Marlene Cavaleiro-Pinto, Bárbara Peleteiro, Nuno Lunet...
https://pubmed.ncbi.nlm.nih.gov/21184266/Martin Weiss, Marcel Arnholdt, Anna Hißnauer...
https://pubmed.ncbi.nlm.nih.gov/37654659/James K Y Hooi, Wan Ying Lai, Wee Khoon Ng...
https://pubmed.ncbi.nlm.nih.gov/28456631/Christopher C. Thompson, MD, MSc
Lead Sponsor
Erbe Elektromedizin GmbH
Collaborating Sponsor