A Prospective Safety and Feasibility Study of the RejuvenAir* System Metered Cryospray Therapy for Chronic Bronchitis Patients.
- Conditions
- Chronic Bronchitis10038716
- Registration Number
- NL-OMON42706
- Lead Sponsor
- CSA MEDICAL, INC.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 15
• Males and females >=40 to <=75 years of age.
• Subject is able to read, understand, and sign a written Informed Consent.
• Subject agrees to continue maintenance pulmonary/COPD medications for the
duration of the study.
• Diagnosis of chronic bronchitis (CB) and chronic obstructive pulmonary disease
(COPD) for a minimum of two years. (Chronic Bronchitis is defined clinically as
chronic productive cough for 3 months in each of 2 successive years in a patient in
whom other causes of productive cough have been excluded.)
• Pre-procedure post bronchodilator FEV1 of greater than or equal to 30% and less
than or equal to 80% of predicted within 3 months of enrollment.
• Smoking history of at least 10 pack years.
• Non-smoking for a minimum of 6 months prior to consent and agrees to continue
not smoking for the duration of the study.
• Subject is able to adhere to and undergo 3 (4 if in Phase A) bronchoscope
procedures that includes lung biopsies and multiple MCS treatments in the
opinion of the investigator or per hospital guidelines. (Only Phase A subjects
receive biopsies)
• Subject has had an acute pulmonary infection or pneumonia within prior 6 weeks
of study bronchoscopy.
• Subject has had a CB and/or COPD exacerbation (requiring steroids and/or
antibiotics) within 6 weeks prior to study bronchoscopy, as defined by their
treating physician
• Subject has clinically significant bronchiectasis or other respiratory disease other
than chronic bronchitis and COPD.
• Diagnosis of asthma with an onset before 30 years of age
• Subject has bullous emphysema characterized as large bullae >30 millimeters on
CT.
• Subject has had a transplant.
• Subject has the inability to walk >140 meters
• Subject has PaC02 >8kPa, or a PaO2<7kPa at room air.
• Subject has a RVSP >45mmHg or a LVEF<45% on 2D-cardiac echo.
• Subject has undergone lung surgery: pneumonectomy, lobectomy, bullectomy,
lung volume reduction surgery
• Subject has had a prior lung device procedure, including emphysema stent(s)
implanted, lung coils, valves, lung denervation or other devices for emphysema.
• Subject is unable to temporarily discontinue use of anticoagulant therapy:
warfarin, Coumadin, LMWH, heparin, clopidrogel (or equal)
• Subject is on >10 mg of prednisolone/day.
• Subject has a serious medical condition, such as: uncontrolled congestive heart
failure, uncontrolled angina, myocardial infarction in the past year, renal failure,
liver disease, cerebrovascular accident within the past 6 months, uncontrolled
diabetes, hypertension, autoimmune disease or uncontrolled gastric reflux
• 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 has known sensitivity to medication required to perform bronchoscopy
(such as lidocaine, atropine, and benzodiazepines).
• Subject has been in another clinical investigational study within 6 weeks of
baseline.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method