630-0012 Pulmonx LIBERATE Study

  • Research type

    Research Study

  • Full title

    Lung Function Improvement after Bronchoscopic Lung Volume Reduction with Pulmonx Endobronchial Valves used in Treatment of Emphysema

  • IRAS ID

    167412

  • Contact name

    Bridget Hurley

  • Contact email

    bhurley@pulmonx.com

  • Sponsor organisation

    Pulmonx Corporation

  • Clinicaltrials.gov Identifier

    NCT01796392

  • Duration of Study in the UK

    7 years, 7 months, 31 days

  • Research summary

    Emphysema is a serious disease afflicting more than four million people worldwide. It 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.

    The purpose of this research is to study a medical device that is designed to reduce the volume of the lung. This device is called the Pulmonx Endobronchial Valve (EBV). 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 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.

    The purpose of this research is to study a medical device that is designed to reduce the volume of the lung. This device is called the Pulmonx Endobronchial Valve (EBV). 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 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.

  • REC name

    London - Stanmore Research Ethics Committee

  • REC reference

    15/LO/0900

  • Date of REC Opinion

    10 Jul 2015

  • REC opinion

    Favourable Opinion