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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.
Ages:40 - 75
Inclusion Criteria: - Clinical andd radiological evidence of emphysema - Currently non-smoking - Stable on current medication regimen - Forced expiratory volume in one second (FEV1) between 15% and 45% of predicted value Exclusion Criteria: - Had less than two hospitalizations over the last year for a COPD exacerbation - Had less than two 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
Sponsor: Pulmonx, Inc.
Trial ID: NCT01796392
Not Accepting Healthy Volunteers