5355W-12: Gorden LIBERATE

CRC 12132: Lung Function Improvement After Bronchoscopic Lung Volume Reduction With Pulmonx Endobronchial Valves Used in Treatment of Emphysema (LIBERATE Study)

Type of Study
Pulmonology
Location
Swedish Thoracic Surgery / First Hill
Short Description

Purpose: The purpose of this research is to study a medical device that is designed to produce lung volume reduction. This device is called the PulmonX Endobronchial Valve (EBV). It has not been approved by the Food and Drug Administration (FDA) and is considered investigational. 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 which allows the healthier parts of the lung to expand.


The EBV can be placed by a doctor in a diseased section of the lungs using bronchoscopy. Bronchoscopy is a way to access the lungs using a small tube with a camera on the end. With bronchoscopy, a physician can reach the airways in the lung by passing the tube through either the mouth or nose. Use of bronchoscopy for performing lung volume reduction may have fewer risks than surgery and have reduced recovery time.
 

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. It is hypothesized that after placement of the EBV, lung function will be improved as compared to standard medical therapy alone.

Status
Open to Enrollment
Principal Investigator
Jed Gorden, M.D.
Eligibility Notes
  • Clinical and radiological evidence of emphysema
  • Currently non-smoking
  • Stable on current medical regimen
  • Forced expiratory volume in one second (FEV1) between 15% and 45% of predicted value
  • No less than two hospitalizations over the last year for a COPD exacerbation
  • No less than two hospitalizations over the last year for pneumonia
  • No prior lung transplant, lung volume reduction surgery, bullectomy or lobectomy
  • No heart attack or congestive heart failure within the last 6 months
  • No heart arrhythmia
  • May not be alpha-1 antitrypsin deficient
More Info Link
Additional information about the study summary and eligibility criteria may be viewed on the U.S. National Institutes of Health (NIH) website.
Phone
(206) 386-2450
Email
christina.brennan@swedish.org