Lung Diseases Clinical Trial
Official title:
A Continuation Study of the AeriSeal® System Administered at 3 to 4 Sites During a Single Treatment Session for Lung Volume Reduction in Patients With Advanced Emphysema
The purpose of this study is to assess the long term safety and efficacy of AeriSeal System treatment administered at up to 4 subsegments during a single treatment session for lung volume reduction in patients with advanced emphysema through 48 weeks after treatment.
Emphysema is a progressive, debilitating disease 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,
occupational, and environmental 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 worldwide. Due to the number of
current and new smokers, emphysema is expected to remain a leading cause of morbidity and
mortality for years to come.
The AeriSeal System is a novel device system being developed for the treatment of advanced
emphysema. The AeriSeal System is administered bronchoscopically, and designed to provide
the physiological benefits of lung volume reduction without the risks and cost of major
surgery.
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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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