H. Pylori Eradication With Argon Plasma During Endoscopy

NCT06529159 | Recruiting

• 1 other identifier: 2024P002031
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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. 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. 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.

Conditions

Helicobacter Pylori Infection; Helicobacter Pylori; Helicobacter Pylori Gastrointestinal Tract Infection; H. Pylori Infection; H. Pylori Gastrointestinal Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Reduction in H. pylori load from baseline to 2 hours after treatment using Urea Breath Test

  Change in measurement H. pylori metabolic activity using the Urea Breath Test (UBT) 1 (+2/-0) day before and 2 (+18/-0) hours after treatment

  Baseline, 2 hours post-treatment

Secondary Outcomes (8)

• Eradication of H. pylori load from 2 hours after treatment to 4 weeks after treatment using Urea Breath Test

  2 hours post-treatment, 4 weeks post-treatment

• Comparison of H. pylori eradication rate between HEAPE + standard of care antibiotic treatment vs standard of care treatment (antibiotics) alone (historical data)

  4 weeks

• Comparison of reduction in H. pylori load measured by UBT HEAPE vs. Pre-HEAPE treatment arms from baseline to 2 hours post-treatment

  Baseline, 2 hours post-treatment

• Comparison of H. pylori load measured by UBT HEAPE vs. Pre-HEAPE treatment arms from baseline to 4 weeks post-treatment

  Baseline, 4 weeks post-treatment

• Change in dyspepsia symptoms from baseline via patient self-report of symptoms

  Baseline, 4 weeks

Study Arms (2)

HEAPE direct

ACTIVE COMPARATOR

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.

Procedure: HEAPE

Pre-HEAPE

ACTIVE COMPARATOR

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.

Procedure: Pre-HEAPE

Interventions

HEAPE PROCEDURE

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

Also known as: Endoscopic APC Treatment in vivo

HEAPE direct

Pre-HEAPE PROCEDURE

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

Also known as: Plasma Activated Liquid (PAL) Administration

Pre-HEAPE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Christopher C. Thompson, MD, MSc: lead
• Erbe Elektromedizin GmbH: collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Related Publications (30)

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MeSH Terms

Interventions

Organization and Administration

Intervention Hierarchy (Ancestors)

Health Services Administration

Study Officials

• Christopher C Thompson, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michele Ryan, MS

CONTACT

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

Samantha Geltz

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open Label
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Endoscopy

Model Details: Two-arm, randomized, pilot, single-center, prospective clinical study

Study Record Dates

• First Submitted: July 26, 2024
• First Posted: July 31, 2024
• Study Start: July 8, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: 12 months after publication
• Access Criteria: IPD requests should be made directly to the PI who will determine feasibility of the request. Institutional data transfer agreement will need to be executed to share data.

Locations

US (1)