Gala Early Feasibility Study of RheOx

Study Overview
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Brief Summary
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An early feasibility study (EFS) to assess the safety and clinical utility of RheOx on patients with chronic bronchitis in the United States.

Detailed Description
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RheOx is a device-based, energy delivery system that delivers energy for the ablation of soft tissue such as 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 anesthesia. 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 tests during the study including three CT scans (lung), respiratory function tests, exercise testing.

Official Title
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A Feasibility Study: A Safety Evaluation of RheOx on Patients With Chronic Bronchitis in the United States

Conditions
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Chronic Bronchitis, Copd Bronchitis

Intervention / Treatment
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* Device: RheOx


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is diagnosed with chronic bronchitis for a minimum of two years, where chronic bronchitis is defined clinically as chronic productive cough for three months in each of two successive years in a patient in whom other causes of productive cough have been excluded. Subject responds to the first two questions of the CAT must sum to at least 7 points. If the sum of the first two CAT questions is 6 points and the subject's total CAT score is greater than 20 points, the subject may be enrolled. Subject has preprocedure post-bronchodilator FEV1 of greater than or equal to 30% and less than or equal to 80% of predicted within three months of enrollment. Subject has had 1 or more COPD exacerbations, defined as an acute worsening in respiratory symptoms that requires additional treatment, in the 12-months prior to enrollment. Subject has a SGRQ score of greater than or equal to 25 and CAT score of greater than or equal to 10. Subject has a cigarette smoking history of at least ten packs years. Subject in the opinion of the site investigator is able to adhere to and undergo two bronchoscopies and has provided a signed informed consent. Exclusion Criteria: Subject has lower respiratory infection (e.g., common cold, pneumonia, MAI, tuberculosis) within the six weeks prior to the initial treatment bronchoscopy or mild or moderate COPD exacerbation (per GOLD guidelines) within 4 weeks of the procedure. Subject is taking > 10 mg of prednisolone or prednisone per day. Subject has an implantable cardioverter defibrillator or pacemaker. Subject has a history of cardiac arrhythmia within past two years. Subject has history of unresolved lung cancer in last 5 years. Subject has bullous disease as defined by bullae exceeding 3 cm in diameter on HRCT. Subject has pulmonary nodule or cavity rthat in the judgement of the investigator may require intervention during the course of the study. Subject has prior lung surgery, such as lung transplant, LVRS, lung implant/prosthesis, metal stent, valves, coils, bullectomy, segmentectomy, or lobectomy. Pneumothorax without lung resection is acceptable. Pleural procedures without surgery are acceptable. Subject has clinically significant cardiomyopathy. Subject has severe bronchiectasis as outlined in the report of the CT scan of the chest by the interpreting radiologist or in the view of the PI, those findings bronchiectasis or any other significant second lung disease, are the main drivers of the patient's clinical symptoms. Subject actively smoked (including tobacco, marijuana, e-cigarettes, vaping, etc.) within the last 6 months. Subject has the inability to walk over 100 meters in 6 minutes. Subject has clinically significant serious medical conditions, such as: congestive heart failure, angina or myocardial infarction in the past year, renal failure, liver disease cerebrovascular accident within the past 6 months, uncontrolled diabetes, uncontrolled hypertension or autoimmune disease. Subject has uncontrolled GERD. Subject has sever pulmonary hypertension. Subject has known sensitivity to medication required to perform bronchoscopy (such as lidocaine, atropine, and benzodiazepines). Subject is pregnant, nursing, or planning to get pregnant during study duration. Subject has received chemotherapy within the past 6 months or is expected to receive chemotherapy during participation in this study. Subject is or has been in another clinical investigational study within 6 weeks of baseline. Subject on anticoagulation for cardiovascular indications and is unable to have anticoagulants (i.e., Aspirin, Plavix, Coumadin) withheld for at least seven days prior to bronchoscopy in the opinion of the Investigator.

Ages Eligible for Study
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Minimum Age: 40 Years

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: Treatment with RheOx
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RheOx Treatment<br>RheOx Treatment (i.e., Bronchial Rheoplasty) | Device: RheOx<br>* RheOx is a 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>* Other names: Gala Airway Treatment System;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Through 12 Months: Rate of Serious Adverse Events | Rate of serious adverse events of interest through 12 months. Events of interest are death, COPD exacerbation requiring hospitalization, pneumothrax within 2 days of procedure, pneumonia within 7 days of procedure, respiratory failure or arrhythmia requiring intervention. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Utility: SGRQ Score at 6 Months | The change from baseline to 6 months in St. George's Respiratory Questionnaire (SGRQ) total score. | 6 months | 
| Clinical Utility: SGRQ Score at 12 Months | The change from baseline to12 months in St. George's Respiratory Questionnaire (SGRQ) total score | 12 months | 
| Clinical Utility: CAT Total Score at 6 Months | The change from baseline to 6 months in COPD Assessment Test (CAT) total score | 6 months | 
| Clinical Utility: CAT Total Score at 12 Months | The change from baseline to 12 months in COPD Assessment Test (CAT) total score | 12 months |