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

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Clinical and 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 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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Eric Edell, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available
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CLS-20143387

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