RheOx Registry Study in Europe

Study Overview
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Brief Summary
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Post-market clinical study (registry study) to collect post-market safety and clinical utility data in European patients with chronic bronchitis treated with RheOx.

Detailed Description
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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.

Official Title
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RheOx European Post-Market Clinical Study

Conditions
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Chronic Bronchitis, COPD

Intervention / Treatment
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* Device: RheOx


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: RheOx Treatment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: RheOx Treatment<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: Incidence of SAEs | Incidence of serious adverse events associated with RheOx treatment through 24 months | Through end of study (24 months post bilateral treatment) | 
| Quality of Life: CAT | COPD Assessment Test (CAT) questionnaire | Through end of study (24 months post bilateral treatment) | 
| Quality of Life: SGRQ | St. George Respiratory Questionnaire | Through end of study (24 months post-bilateral treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary Function: FEV1 | Forced expiratory volume (FEV). FEV1 is the amount of air you can force from your lungs in one second. | Through end of study (24 months post-bilateral treatment) | 
| Pulmonary Function: FVC | Forced Vital Capacity | Through end of study (24 months post-bilateral treatment) | 
| COPD Exacerbations | COPD Exacerbations | Through end of study (24 months post-bilateral treatment) |