Pulmonary Emphysema Clinical Trial
Official title:
Phase 1/Phase 2 Study of the Aeris Bronchoscopic Lung Volume Reduction (BLVR) System in Patients With Advanced Emphysema
The purpose of this study is to evaluate the safety and efficacy of the Aeris BLVR System in patients with advanced emphysema.
Emphysema is a progressive, debilitating disease that affects nearly 3 million people in the
United States or roughly one percent of the US population. The disease is characterized by
destruction of lung tissue as a result of inflammation caused by exposure to noxious inhaled
agents for extended periods. The most common cause of this condition is cigarette smoking,
although genetic and occupational causes account for up to 10% of cases. Despite aggressive
public health initiatives aimed at discouraging the use of cigarettes, smoking-related lung
diseases remain a significant cause of disability and death in the United States. Currently
there are 46 million smokers in the US. Due to the number of current and new smokers,
emphysema is expected to remain a leading cause of morbidity and mortality in the United
States for years to come.
Aeris has developed a novel bronchoscopic system for achieving the benefits of lung volume
reduction without surgery. The Bronchoscopic Lung Volume Reduction (BLVR) Hydrogel System, a
new investigational therapy for emphysema, is intended to reduce lung volume over a period
of weeks by collapsing and promoting the remodeling of diseased areas of the lung. The
resulting reduction in lung volume is intended to restore a more normal physiological
relationship between lung and chest wall, improve breathing and exercise capacity and
alleviate symptoms of chronic dyspnea. The current study will evaluate the safety and
efficacy of this procedure in patients with advanced emphysema.
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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