H. Pylori Eradication With Argon Plasma During Endoscopy
NCT Number: NCT06529159
Acronym: HEAPE
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Helicobacter Pylori Infection|Helicobacter Pylori|Helicobacter Pylori Gastrointestinal Tract Infection|H. Pylori Infection|H. Pylori Gastrointestinal Disease
Interventions: PROCEDURE: HEAPE|PROCEDURE: Pre-HEAPE
Sponsor: Christopher C. Thompson, MD, MSc
Collaborators: Erbe Elektromedizin GmbH
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-15
Completion Date: 2025-12-01
Locations: Brigham and Women's Hospital, Boston, Massachusetts, 02115, United States

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.

Primary Outcome Measures: 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 Outcome Measures: Eradication of H. pylori load from 2 hours after treatment to 4 weeks after treatment using Urea Breath Test, H. pylori eradication (negative UBT) directly after the HEAPE treatment (timepoint 1) and 4 (+2/-0) weeks after HEAPE treatment (timepoint 2), 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), Comparison of eradication rates at 4 weeks between patients treated with HEAPE + antibiotics vs. published literature using UBT values, 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, Comparison of the reduction in H. pylori load, as measured by Urea Breath Test (UBT), 2 (+18/-0) hours after treatment between the HEAPE direct modality and the Pre-HEAPE modality, 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, Comparison of the reduction in H. pylori load, as measured by Urea Breath Test (UBT), 4 weeks after treatment between the HEAPE direct modality and the Pre-HEAPE modality, Baseline, 4 weeks post-treatment|Change in dyspepsia symptoms from baseline via patient self-report of symptoms, Change in patient self-report of dyspepsia symptoms from baseline up to 4 weeks post-treatment, Baseline, 4 weeks|Change in epigastric pain level from baseline via patient self-report of symptoms using the Abdominal Pain Index, Change in patient self-report of epigastric pain level from baseline up to 4 weeks post-treatment using Abdominal Pain Index (from no pain (0) to the most pain possible (10))., Baseline, 4 weeks|Change in quality of life score from baseline using the 12 item Short Form Survey (SF-12), Comparison of quality of life scores from baseline to 4 weeks post-treatment using the SF-12 scoring system. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning. A score of 50 or less has been recommended as a cut-off to determine a physical condition in the Physical Health Composite Score (PCS) section; while a score of 42 or less may be indicative of 'clinical depression' Mental Health Composite Score (MCS) section., Baseline, 4 weeks|Adverse Events intra-procedural and post-treatment, Presence of adverse events that develop post-procedure, Intra-procedure, 2 hours post-treatment, 4 weeks post-treatment