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Summary

for people ages 40–75 (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

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.

Official Title

Lung Function Improvement After Bronchoscopic Lung Volume Reduction With Pulmonx Endobronchial Valves Used in Treatment of Emphysema

Details

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.

Keywords

Emphysema endobronchial valve treatments pulmonary rehabilitation lung volume reduction

Eligibility

You can join if…

Open to people ages 40–75

  • 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

You CAN'T join 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

Locations

  • Stanford University
    Stanford, California, 94507, United States
  • El Camino Hospital
    Mountain View, California, 94040, United States
  • University of California at Davis Medical Center
    Sacramento, California, 95817, United States
  • University of Southern California
    Los Angeles, California, 90033, United States
  • Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
    Torrance, California, 90502, United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Pulmonx, Inc.
ID
NCT01796392
Lead Scientist
Steven Hays
Study Type
Interventional
Last Updated
September 2016