NCT01796392

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 190 (actual)
• Sponsor: Pulmonx Corporation · Industry
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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. Based on the 12-month follow up data from the LIBERATE Study, the Zephyr Endobronchial Valve System was approved by the FDA for the treatment of severe emphysema in June 2018. Following this PMA approval, and in agreement with the FDA, the ongoing long term follow-up (out to 5 years) of patients in the LIBERATE Study will now be conducted as a Post-approval study under the auspices of the "LIBERATE Extension Study". This is an administrative change with absolutely no change to the design or conduct of the study and, therefore has no material impact to the study participants or the study sites. All annual follow-up visits and evaluations are per the original LIBERATE Study protocol. Reporting to the FDA will be as the LIBERATE Extension Study.

Conditions

• Emphysema

Interventions

Type	Name	Description
DEVICE	EBV	This study arm will undergo EBV treatment and also receive optimal medical management, including smoking cessation program support, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.
OTHER	Optimal Medical Management	This study arm will receive optimal medical management, including smoking cessation program support, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.

Timeline

• Start date: 2013-07-01
• Primary completion: 2017-09-01
• Completion: 2023-04-01
• First posted: 2013-02-21
• Last updated: 2023-06-15
• Results posted: 2019-03-05

Locations

23 sites across 4 countries: United States, Brazil, Netherlands, United Kingdom