Pulmonx Endobronchial Valves Used in Treatment of Emphysema (LIBERATE Study)
NCT ID: NCT01796392
Last Updated: 2023-06-15
Study Results
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View full resultsBasic Information
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COMPLETED
NA
190 participants
INTERVENTIONAL
2013-07-31
2023-04-30
Brief Summary
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Detailed Description
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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.
Based on the 12-month follow up data from the LIBERATE Study, the Zephyr Endobronchial Valve System was approved by the FDA for the treatment of severe emphysema in June 2018. Following this PMA approval, and in agreement with the FDA, the ongoing long term follow-up (out to 5 years) of patients in the LIBERATE Study will now be conducted as a Post-approval study under the auspices of the "LIBERATE Extension Study". This is an administrative change with absolutely no change to the design or conduct of the study and, therefore has no material impact to the study participants or the study sites. All annual follow-up visits and evaluations are per the original LIBERATE Study protocol. Reporting to the FDA will be as the LIBERATE Extension Study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
EBV
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.
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.
Interventions
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EBV
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 optimal medical management, including smoking cessation program support, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
40 Years
75 Years
ALL
No
Sponsors
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Pulmonx Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Gerard Criner, MD
Role: PRINCIPAL_INVESTIGATOR
Temple University Hospital, Philadelphia, PA
Locations
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The University of Alabama at Birmingham
Birmingham, Alabama, United States
Arizona Pulmonary Specialists
Phoenix, Arizona, United States
University of Southern California
Los Angeles, California, United States
El Camino Hospital
Mountain View, California, United States
University of California at Davis Medical Center
Sacramento, California, United States
University of California, San Francisco
San Francisco, California, United States
Stanford University
Stanford, California, United States
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
Torrance, California, United States
Orlando Health
Orlando, Florida, United States
University of Louisville Research Foundation
Louisville, Kentucky, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Duke University Medical Center
Durham, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Houston Methodist Hospital
Houston, Texas, United States
Hospital de Clinicas Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
INCOR - Hospital das Clinicas de Faculdade de Medicine da USP
São Paulo, São Paulo, Brazil
University Medical Center Groningen
Groningen, , Netherlands
Bristol Royal Infirmary
Bristol, , United Kingdom
University Hospital Llandough and University Hospital of Wales
Cardiff, , United Kingdom
Royal Brompton & Harefield NHS Foundation Trust
London, , United Kingdom
Countries
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References
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Bakker JT, Hartman JE, Klooster K, Charbonnier JP, Tsiaousis M, Vliegenthart R, Slebos DJ. Endobronchial valve treatment improves chest-CT diaphragm configuration in COPD. Respir Med. 2024 Nov-Dec;234:107856. doi: 10.1016/j.rmed.2024.107856. Epub 2024 Nov 6.
Dransfield MT, Garner JL, Bhatt SP, Slebos DJ, Klooster K, Sciurba FC, Shah PL, Marchetti NT, Sue RD, Wright S, Rivas-Perez H, Wiese TA, Wahidi MM, Goulart de Oliveira H, Armstrong B, Radhakrishnan S, Shargill NS, Criner GJ; LIBERATE Study Group:. Effect of Zephyr Endobronchial Valves on Dyspnea, Activity Levels, and Quality of Life at One Year. Results from a Randomized Clinical Trial. Ann Am Thorac Soc. 2020 Jul;17(7):829-838. doi: 10.1513/AnnalsATS.201909-666OC.
Criner GJ, Sue R, Wright S, Dransfield M, Rivas-Perez H, Wiese T, Sciurba FC, Shah PL, Wahidi MM, de Oliveira HG, Morrissey B, Cardoso PFG, Hays S, Majid A, Pastis N Jr, Kopas L, Vollenweider M, McFadden PM, Machuzak M, Hsia DW, Sung A, Jarad N, Kornaszewska M, Hazelrigg S, Krishna G, Armstrong B, Shargill NS, Slebos DJ; LIBERATE Study Group. A Multicenter Randomized Controlled Trial of Zephyr Endobronchial Valve Treatment in Heterogeneous Emphysema (LIBERATE). Am J Respir Crit Care Med. 2018 Nov 1;198(9):1151-1164. doi: 10.1164/rccm.201803-0590OC.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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600-0012
Identifier Type: -
Identifier Source: org_study_id
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