Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06529159

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 world's 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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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)

Follow-up

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)

Trial Site Locations

Total: 1 location

1

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02115

Actively Recruiting

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Research Team

M

Michele Ryan, MS

S

Samantha Geltz

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Rates of Antimicrobial Resistance in Helicobacter pylori Isolates From Clinical Trial Patients Across the US and Europe.

Francis Mégraud, David Y Graham, Colin W Howden...

https://pubmed.ncbi.nlm.nih.gov/36191284

Helicobacter pylori infection treatment in the United States: clinical consequences and costs of eradication treatment failure.

Shailja Shah, Elizabeth Hubscher, Corey Pelletier...

https://pubmed.ncbi.nlm.nih.gov/35315732