Lung Function Improvement after Bronchoscopic Lung Volume Reduction with Pulmonx Endobronchial Valves used in Treatment of Emphysema (LIBERATE)
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Phase: Pivotal
Status: Not Recruiting
The purpose of this research is to study a medical device designed to produce lung volume reduction for people suffering from emphysema. This device is called the Pulmonx Endobronchial Valve (EBV). Emphysema is a serious disease and is one form of Chronic Obstructive Pulmonary Disease, or COPD. Emphysema causes the lungs to lose the ability to move air in and out normally and to efficiently absorb oxygen. Eventually, breathing becomes more difficult as damaged parts of the lungs trap air. As the disease advances, the damaged, inelastic areas of the lung progressively expand within the chest cavity, leaving one constantly feeling out of breath. This study is designed to investigate the safety and effectiveness of the Pulmonx EBV for treating emphysema symptoms as compared to a standard medical therapy program alone. The EBV is a one-way valve that blocks off the diseased lung section to inhaled air but lets the trapped air already inside the area escape. With placement of the EBV, the diseased part of the lung collapses; this allows the healthier parts of the lung to expand. The EBV is considered experimental. This means that it has not yet been approved by the U.S. FDA (Food and Drug Administration) for commercial use in the United States.
Principal Investigator
Ganesh Krishna, MD, Palo Alto Medical Foundation
Sponsor
Pulmonx, Inc.
NCT Number
NCT01796392
Contact
Janet Lamm, Clinical Research Coordinator
El Camino Hospital Clinical Research Department
650-962-4566
janet_lamm@elcaminohealth.org
For more information about this clinical trial, including trial status, eligibility and full trial listing, visit www.clinicaltrials.gov.