Observational Study of Zephyr Endobronchial Valve Use for Lung Volume Reduction in Adults with Severe Emphysema in Japan

What this Trial Is About

Researchers are observing adults with severe emphysema and lung hyperinflation who are considered suitable for bronchoscopic lung volume reduction BLVR using the Zephyr Endobronchial Valve. This multicenter, prospective surveillance study involves 140 patients across up to 20 centers in Japan. The study aims to monitor safety and effectiveness over 12 months, focusing on lung function, exercise ability, breathing difficulties, and quality of life. Participants confirmed to have little or no collateral ventilation in the target lung lobe will undergo a bronchoscopy with Chartis assessment, followed by placement of the Zephyr Valve in the most affected lobe. Patients will be hospitalized for at least three nights for observation after the procedure. Those with collateral ventilation will not receive treatment and will exit the study. Participants will complete a pulmonary rehabilitation program between 45 days and 3 months after the procedure. Throughout the 12-month follow-up, lung function tests measuring forced expiratory volume in 1 second, residual volume, and a 6-minute walk test will be conducted at 3, 6, and 12 months. High-resolution CT scans will assess lung volume reduction at 45 days and 12 months. Safety is assessed by tracking treatment-related adverse events, especially the incidence of pneumothorax within 45 days after valve placement.

Zephyr Valve Japan Post-Marketing Surveillance