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.
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 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
Parallel
HEAPE
Procedure/SurgeryThe stomach is filled with sodium chloride solution which is then treated with APC to activate it into an antibacterial solution.
Pre-HEAPE
Procedure/SurgeryPlasma activated sodium chloride solution (prepared outside of the body) is administered into the patients stomach through an endoscope channel using a syringe.
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
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)
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
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
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
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Christopher C. Thompson, MD, MSc
Lead sponsor
Brigham and Women's Hospital
Sponsor institution
Erbe Elektromedizin GmbH
Collaborator
