Status:
COMPLETED
Pulmonx Endobronchial Valves Used in Treatment of Emphysema (LIBERATE Study)
Lead Sponsor:
Pulmonx Corporation
Conditions:
Emphysema
Eligibility:
All Genders
40-75 years
Phase:
NA
Brief Summary
The purpose of this research is to study an investigational medical device that is designed to produce lung volume reduction in diseased areas of the lungs in patients with severe emphysema.
Detailed Description
The Pulmonx Zephyr Endobronchial Valve (EBV) is an implantable bronchial valve intended to decrease volume in targeted regions of the lung. It is indicated for the treatment of patients with severe em...
Eligibility Criteria
Inclusion
- Clinical and radiological evidence of emphysema
- Nonsmoking for 4 months prior to screening interview
- BMI less than 35 kg/m2
- Stable on current medication regimen
- Forced expiratory volume in one second (FEV1) between 15% and 45% of predicted value
- Residual Volume less than 175% predicted (determined by body plethysmography)
- Little or no collateral ventilation (CV-) as determined using the Chartis System
Exclusion
- Had two or more hospitalizations over the last year for a COPD exacerbation
- Had two or more hospitalizations over the last year for pneumonia
- Had a prior lung transplant, lung volume reduction surgery, bullectomy or lobectomy
- Had a heart attack or congestive heart failure within the last 6 months
- Have heart arrhythmia
- Is alpha-1 antitrypsin deficient
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2023
Estimated Enrollment :
190 Patients enrolled
Trial Details
Trial ID
NCT01796392
Start Date
July 1 2013
End Date
April 1 2023
Last Update
June 15 2023
Active Locations (23)
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1
The University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249
2
Arizona Pulmonary Specialists
Phoenix, Arizona, United States, 85012
3
University of Southern California
Los Angeles, California, United States, 90033
4
El Camino Hospital
Mountain View, California, United States, 94040