Eradicating H. Pylori with Argon Plasma During Endoscopy
H. Pylori Eradication With Argon Plasma During Endoscopy (HEAPE)
This study is testing a new argon plasma treatment during endoscopy to see if it can safely get rid of H. pylori infections in patients who haven't been treated yet.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06529159 on ClinicalTrials.gov |
What this trial studies
This study investigates the efficacy and safety of a novel argon plasma-based therapy, known as HEAPE, for treating H. pylori infections during endoscopic procedures. The approach involves filling the stomach with a sodium chloride solution treated with plasma activated liquid (PAL), which aims to reduce H. pylori without the thermal damage associated with traditional methods. Two different modalities of PAL generation will be compared to assess their effectiveness. The study targets patients with confirmed untreated H. pylori infections undergoing upper endoscopy.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with confirmed untreated H. pylori infections scheduled for upper endoscopy.
Not a fit: Patients currently undergoing H. pylori eradication therapy or those with severe cardiopulmonary diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a safer and more effective method for eradicating H. pylori infections, potentially reducing the risk of gastric cancer.
How similar studies have performed: While traditional treatments for H. pylori have shown success, this novel approach using argon plasma is relatively untested, making it a potentially groundbreaking method.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Boston, Massachusetts
- Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Christopher C Thompson, MD — Brigham and Women's Hospital
- Study coordinator: Michele Ryan, MS
- Email: mryan@bwh.harvard.edu
- Phone: 617-525-8266
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.