Registry for RheOx treatment in chronic bronchitis patients in Europe
RheOx European Post-Market Clinical Study
This study is testing a new device called RheOx to see if it can safely help people in Europe with chronic bronchitis feel better after two treatment sessions.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Sex | All |
| Sponsor | Gala Therapeutics, Inc. Industry-sponsored |
| Locations | 2 sites (Wien and 1 other locations) |
| Trial ID | NCT04182841 on ClinicalTrials.gov |
What this trial studies
This registry study aims to collect post-market safety and clinical utility data for the RheOx device in European patients suffering from chronic bronchitis. The RheOx system delivers high-frequency energy to the airway epithelium and sub-mucosal tissues via a catheter during bronchoscopic procedures. Patients will undergo two treatment sessions, one month apart, with the right lung treated first and the left lung treated subsequently. The study will involve various respiratory function tests and questionnaires to assess the treatment's effectiveness.
Who should consider this trial
Good fit: Ideal candidates are individuals with moderate to severe chronic bronchitis.
Not a fit: Patients with implantable electronic devices or significant arrhythmias may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve respiratory function and quality of life for patients with chronic bronchitis.
How similar studies have performed: While this approach is innovative, similar device-based treatments have shown promise in other studies, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient has moderate to severe Chronic Bronchitis Exclusion Criteria: * Patient has an implantable cardioverter defibrillator, pacemaker, or any other implantable electronic device. * Patient has history of ventricular tachyarrhythmia or any clinically significant atrial tachyarrhythmia (i.e., abnormality with vital signs) and/or history of type II second or third degree AV block. * Patient has airway stent(s), valves, coils, or other lung implant/prosthesis.
Where this trial is running
Wien and 1 other locations
- Otto Wagner Spital — Wien, Austria (Recruiting)
- Pneumologie Thoraxklinik Heidelberg gGmbH University of Heidelberg — Heidelberg, Baden-Württemberg, Germany (Recruiting)
Study contacts
- Study coordinator: Jeff Keeney
- Email: jeff@galatherapeutics.com
- Phone: 650-268-4252
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.