Recruiting

Argon Plasma

Sponsor:

Christopher C. Thompson, MD, MSc

Code:

NCT06529159

Conditions

Helicobacter Pylori Infection

Helicobacter Pylori

Helicobacter Pylori Gastrointestinal Tract Infection

H. Pylori Infection

H. Pylori Gastrointestinal Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

HEAPE

Pre-HEAPE

Study Details

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 with sodium chloride solution that is treated with APC (PAL), the Investigators hypothesize a significant reduction in H. pylori. The use of PAL instead of direct application of APC allows for a broader and more homogeneous application throughout the stomach and a faster procedure time, as the fluid bypasses the thermal effects typically associated with higher electrical power settings and focuses on the bactericidal action of PAL. It is a procedure that does not involve thermal ablation of the stomach lining. Thus, side effects should be expected to be as low as possible.

Two different PAL generation modalities will be compared in this study:

1. HEAPE direct: This modality is the direct generation of PAL in the stomach. The stomach is filled with sodium chloride solution which is then treated with APC. With HEAPE direct a potential decrease of reactive species is avoided, as the treatment happens directly at the intended location in the H. pylori infected stomach.
2. Pre-HEAPE: This modality features the treatment of sodium chloride with APC outside of the patient in a sterile container. After the APC treatment, the generated PAL is administered into the stomach with a syringe through the working channel of the endoscope. Pre-HEAPE allows an easier handling of the APC probe as the treatment of the sodium chloride solution can be done without an endoscope.

To evaluate the immediate effect of this novel treatment approach the metabolic activity of H. pylori will be assessed using a urea breath test (UBT) before and after treatment. A reduction in H. pylori levels can be detected by a reduction in urease activity in the breath test.

After the HEAPE procedure, patients are treated with antibiotics (best practice) as they would be under normal circumstances. Four weeks after treatment, another UBT is performed to determine if H. pylori has been eradicated or if additional antibiotic treatment is indicated.

This two-arm, randomized, pilot, single-center, prospective clinical study is designed to evaluate the safety, tolerability and proof of concept that PAL has the ability to eradicate or reduce the bacterial load of H. pylori in humans.

Conditions

Helicobacter Pylori Infection

Helicobacter Pylori

Helicobacter Pylori Gastrointestinal Tract Infection

H. Pylori Infection

H. Pylori Gastrointestinal Disease

Study ID

NCT06529159

Start date

Jul 8, 2025

Status verified date

Feb, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: HEAPE direct

This modality is the direct generation of PAL in the stomach. The stomach is filled with sodium chloride solution which is then treated with APC. With HEAPE direct a potential decrease of reactive species is avoided, as the treatment happens directly at the intended location in the H. pylori infected stomach.

active comparator: Pre-HEAPE

This modality features the treatment of sodium chloride with APC outside of the patient in a sterile container. After the APC treatment, the generated PAL is administered into the stomach with a syringe through the working channel of the endoscope. Pre-HEAPE allows an easier handling of the APC probe as the treatment of the sodium chloride solution can be done without an endoscope.

Interventions

HEAPE

The stomach is filled with sodium chloride solution which is then treated with APC to activate it into an antibacterial solution.

Pre-HEAPE

Plasma activated sodium chloride solution (prepared outside of the body) is administered into the patients stomach through an endoscope channel using a syringe.

Primary outcome measure

  • Reduction in H. pylori load from baseline to 2 hours after treatment using Urea Breath Test [ Time Frame: Baseline, 2 hours post-treatment ]

Central Contacts and Locations

Central contacts

Michele Ryan, MS

617-525-8266mryan@bwh.harvard.edu

Samantha Geltz

617-732-5174sgeltz@bwh.harvard.edu

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Michele B. Ryan, MS

6175258266mryan@bwh.harvard.edu

Principal Investigator:

Christopher C. Thompson, MD, MSc

More Information

Sponsor

Christopher C. Thompson, MD, MSc

Last update posted

Mar 2, 2026

Last verified

Feb, 2026

Keywords

  • Urea Breath Test
  • Argon Plasma Coagulation (APC)
  • Endoscopy
  • Plasma Activated Liquid (PAL)
  • Plasma Medicine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Christopher C. Thompson, MD, MSc on 2026-03-02.