RheOx Registry Study in Europe
Study Details
Study Description
Brief Summary
Post-market clinical study (registry study) to collect post-market safety and clinical utility data in European patients with chronic bronchitis treated with RheOx.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
RheOx is a device-based, energy delivery system that delivers high frequency short duration energy to the airway epithelium and sub-mucosal tissue layers. The energy is delivered via a proprietary catheter through the bronchoscope.
Two sessions of treatment will be delivered one month apart. The right lung is treated at the first treatment session and the left lung is treated at the second treatment session (approximately one month after the right side is treated). Treatment will be delivered by a respiratory physician (interventional pulmonologist) in a tertiary teaching hospital during a bronchoscopic procedure. The bronchoscopy will be delivered during general anaesthesia. It is anticipated that the bronchoscopic procedure will last less than 60 minutes in total. Treatment will be deemed to have been delivered following the successful treatment during the two bronchoscopies.
Subjects will be required to submit to several tests and questionnaires during the study including respiratory function tests.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: RheOx Treatment RheOx is a CE-marked device-based, energy delivery system that delivers energy to ablate soft tissue such as the airway epithelium and sub-mucosal tissue layers. The energy is delivered via a proprietary catheter through the bronchoscope. |
Device: RheOx
RheOX is a CE-marked device-based, energy delivery system that delivers energy to ablate soft tissue such as the airway epithelium and sub-mucosal tissue layers. The energy is delivered via a proprietary catheter through the bronchoscope.
|
Outcome Measures
Primary Outcome Measures
- Safety: Incidence of SAEs [Through end of study (24 months post bilateral treatment)]
Incidence of serious adverse events associated with RheOx treatment through 24 months
- Quality of Life: CAT [Through end of study (24 months post bilateral treatment)]
COPD Assessment Test (CAT) questionnaire
- Quality of Life: SGRQ [Through end of study (24 months post-bilateral treatment)]
St. George Respiratory Questionnaire
Secondary Outcome Measures
- Pulmonary Function: FEV1 [Through end of study (24 months post-bilateral treatment)]
Forced expiratory volume (FEV). FEV1 is the amount of air you can force from your lungs in one second.
- Pulmonary Function: FVC [Through end of study (24 months post-bilateral treatment)]
Forced Vital Capacity
- COPD Exacerbations [Through end of study (24 months post-bilateral treatment)]
COPD Exacerbations
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Otto Wagner Spital | Wien | Austria | A-1140 | |
| 2 | Pneumologie Thoraxklinik Heidelberg gGmbH University of Heidelberg | Heidelberg | Baden-Württemberg | Germany | 69047 |
Sponsors and Collaborators
- Gala Therapeutics, Inc.
Investigators
- Study Director: William Krimsky, MD, Gala Therapeutics, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CS005