Pulmonx Endobronchial Valves Used in Treatment of Emphysema (LIBERATE Study)

Completed · Not applicable

Conditions studied: Emphysema

In brief

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.

Key facts

Study ID

NCT01796392

Run by

Pulmonx Corporation

People needed

190

Starts

2013-07-01

Expected to finish

2023-04-01

Last updated by the study team

2023-06-15

Who can join

Age: 40 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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