NL-OMON42116
Completed
Not Applicable
ung Function Improvement after Bronchoscopic Lung Volume Reduction with Pulmonx Endobronchial Valves used in Treatment of Emphysema - LIBERATE STUDY
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- COPD emphysema
- Sponsor
- PulmonX International Sarl
- Enrollment
- 24
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Signed Screening or Study Procedure Informed Consent using a form that was reviewed and approved by the IRB;
- •2\. Age 40 to 75 years;
- •3\. BMI less than 35 kg/m2;
- •4 Stable with less than 20 mg prednisone (or equivalent) per day;
- •5 Nonsmoking for 4 months prior to screening interview.
- •6\.Completed a supervised pulmonary rehabilitation program less than equal to 6 months prior to the baseline exam or is regularly performing maintenance respiratory rehabilitation if initial supervised therapy occurred greater than 6 months prior
- •7\.FEV1 between 15% and 45% of predicted value at baseline exam
- •Post\-rehabilitation 6\-minute walk distance between 100 meters and 500 meters at baseline exam
- •8\.Current Pneumococcus vaccination \& Current Influenza vaccination
- •9\.Little or no collateral ventilation (CV\-) as determined using the Chartis System
Exclusion Criteria
- •1\. Currently enrolled in another clinical trial studying an experimental treatment;
- •2\. Previously enrolled in this study for which protocol required follow up is not complete;
- •3\. Clinically significant (greater than 4 tablespoons per day) sputum production;
- •4\. Two or more COPD exacerbation episodes requiring hospitalization in the last year at screening;
- •5\. Two or more instances of pneumonia episodes in the last year at screening;
- •6\. Unplanned weight loss \>10% usual weight \<90 days prior to enrollment;
- •7\. History of exercise\-related syncope;
- •8\. Myocardial Infarction or congestive heart failure within 6 months of screening;
- •9\. Prior lung transplant, LVRS, bullectomy or lobectomy;
- •10\. Clinically significant bronchiectasis;
Outcomes
Primary Outcomes
Not specified
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