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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Not applicable. Follow-Up study only.
The Soroka Medical Center
Beersheba, Israel
The Rabin Medical Center
Petah Tikva, Israel
Change from baseline in Percent Volume of Lung
Computed Tomography (CT) evidence of lobar volume reduction at site(s) of AeriSeal Foam Sealant administration at 48 weeks post treatment, assessed quantitatively by digital integration of CT dicom images collected using a standardized image acquisition and reconstruction algorithm.
Time frame: 48 Weeks following treatment
Change in the ratio of Residual Volume (RV) to Total Lung Capacity (TLC)
Change from baseline at 24 and 48 weeks in RV/TLC
Time frame: 24 and 48 weeks following treatment
Change in Forced Expiratory Volume in 1 Second (FEV1)
Change from baseline at 24 and 48 weeks in FEV1
Time frame: 24 and 48 weeks following treatment
Change in Forced Vital Capacity (FVC)
Change from baseline at 24 and 48 weeks in FVC
Time frame: 24 and 48 weeks following treatment
Change in distance walked in six minutes
Change from baseline at 24 and 48 weeks in 6 Minutes Walk Test (6MWT)
Time frame: 24 and 48 weeks following treatment
Change in Medical Research Council Dyspnea (MRCD) score
Change from baseline at 24 and 48 weeks in MRCD score
Time frame: 24 and 48 weeks following treatment
Change in St. George's Respiratory Questionnaire (SGRQ)domain score
Change from baseline at 24 and 48 weeks in SGRQ total domain score
Time frame: 24 and 48 weeks following treatment
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