Pulmonx Endobronchial Valves Used in Treatment of Emphysema (LIBERATE Study) (LIBERATE)
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|ClinicalTrials.gov Identifier: NCT01796392|
Recruitment Status : Active, not recruiting
First Posted : February 21, 2013
Last Update Posted : November 27, 2017
|Condition or disease||Intervention/treatment||Phase|
|Emphysema||Device: EBV Other: Optimal Medical Management||Not Applicable|
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 emphysema. The EBV are placed in the diseased region of the lung using bronchoscopy. Bronchoscopy is a way to access the lungs using a small tube with a camera on the end. As the diseased region of the lung shrinks in size, healthier regions may expand and function more efficiently, resulting in improved breathing.
The LIBERATE Study is a clinical trial with two groups. Participants are assigned at random to the 'Treatment' group or to the 'Control' group. The 'Treatment' group will receive the Zephyr Endobronchial Valve (EBV) in combination with optimal medical therapy. The 'Control' group will receive optimal medical therapy alone. For every three participants in the study, two will go into the 'Treatment' group and one will go into the 'Control' group.
It is hypothesized that after placement of the EBV, lung function will be improved as compared to standard medical therapy alone.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||190 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Lung Function Improvement After Bronchoscopic Lung Volume Reduction With Pulmonx Endobronchial Valves Used in Treatment of Emphysema|
|Actual Study Start Date :||July 2013|
|Actual Primary Completion Date :||September 2017|
|Estimated Study Completion Date :||November 2022|
Experimental: EBV and Optimal Medical Management
This study arm will undergo EBV treatment along with optimal medical management, including smoking cessation program, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.
This study arm will undergo EBV treatment and also receive optimal medical management, including smoking cessation program support, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.
Optimal Medical Management
This study arm will receive maximal medical management, including smoking cessation program support if necessary, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.
Other: Optimal Medical Management
This study arm will receive optimal medical management, including smoking cessation program support, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.
- Forced expiratory volume in 1-second (FEV1) [ Time Frame: 1 year ]The percentage of study participants in the EBV (Endobronchial Valves) treatment arm meeting the clinically significant threshold of >15% improved forced expiratory volume in one second (FEV1), obtained immediately following bronchodilator therapy, as compared to the percentage in the control arm at 1 year post-procedure.
- Volumetric reduction of the treated area of the lung [ Time Frame: 1 year ]Treatment Lobe Volume Reduction (TLVR) for the treatment arm, measured as the 'absolute and percentage change from baseline' for treated lobe volume as seen via HRCT (high resolution computed tomography), will be evaluated at 45 days and 1 year.
- St. George's Respiratory Questionnaire (SGRQ) [ Time Frame: 1 year ]Difference between study arms in 'absolute change from baseline' for SGRQ score at 1 year.
- 6-minute walk distance [ Time Frame: 1 year ]Difference between study arms in 'absolute and percentage change from baseline' for 6MWD at 1 year.
- Adverse Events [ Time Frame: 1 Year ]Evaluation of the short- and long-term adverse events profile of the EBV treatment arm during the treatment period, defined as the day of the study procedure until 45 days after the study procedure (short), and in the post-treatment period, defined as 46 days after the study procedure until the 1-year follow-up visit (long).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01796392
Show 23 Study Locations
|Principal Investigator:||Gerard Criner, MD||Temple University Hospital, Philadelphia, PA|