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NCT06529159 · ClinicalTrials.gov registry record · NA
H. Pylori Eradication With Argon Plasma During Endoscopy
A NA study of Helicobacter Pylori Infection and Helicobacter Pylori, sponsored by Christopher C. Thompson, MD, MSc.
- Recruiting
- Registry status
- NA
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT06529159: Recruiting NA study of Helicobacter Pylori Infection and Helicobacter Pylori, sponsored by Christopher C. Thompson, MD, MSc.
NCT06529159 is a NA study of Helicobacter Pylori Infection and Helicobacter Pylori that is actively recruiting participants, run by Christopher C. Thompson, MD, MSc. The registered enrollment target is 20 participants, below the 361-participant average among 4 other Helicobacter Pylori Infection trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06529159, a NA study of Helicobacter Pylori Infection and Helicobacter Pylori, is actively recruiting participants, sponsored by Christopher C. Thompson, MD, MSc.
- RECRUITING
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study 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 af
Primary Outcome
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
Conditions Studied
Interventions
- PROCEDURE HEAPE
- PROCEDURE Pre-HEAPE
Study Locations (1)
Massachusetts
- Brigham and Women's Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2025-07-08 |
| Est. Completion | 2027-12 |
| Phase | NA |
What NCT06529159 shows while recruiting
NCT06529159 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 361-participant average among 4 other Helicobacter Pylori Infection trials with a reported enrollment target (94% lower).
The record links to 5 conditions, with Helicobacter Pylori Infection appearing as the primary indexed condition, and to 2 interventions - of which HEAPE is the first listed.
NCT06529159 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT06529159 about?
NCT06529159 is a clinical study titled "H. Pylori Eradication With Argon Plasma During Endoscopy". 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 signific...
What is the current status of trial NCT06529159?
This trial is currently recruiting. It is a NA study. The enrollment target is 20 participants. The study started on 2025-07-08. Estimated completion is 2027-12.
What conditions does trial NCT06529159 study?
This clinical trial studies the following conditions: Helicobacter Pylori Infection, Helicobacter Pylori, H. Pylori Infection, Helicobacter Pylori Gastrointestinal Tract Infection, H. Pylori Gastrointestinal Disease.
What interventions are being tested in trial NCT06529159?
The interventions under investigation include: HEAPE (PROCEDURE), Pre-HEAPE (PROCEDURE).
Who is sponsoring clinical trial NCT06529159?
This trial is sponsored by Christopher C. Thompson, MD, MSc, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06529159 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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