The purpose of this study is to characterize the safety and efficacy of the AeriSeal System in patients with advanced upper lobe predominant emphysema and significant collateral ventilation as determined by the Chartis System.
This is an investigator initiated, open-label, uncontrolled study to prospectively characterize the safety and efficacy of the AeriSeal System in patients with advanced upper lobe predominant emphysema found to have significant collateral ventilation using the Chartis System.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
10
20 mL
Otto-Wagner-Spital
Vienna, Austria
RECRUITINGChange in Forced Expiratory Volume in one second (FEV1)
Change from baseline in FEV1 measurement after 12 weeks following completion of therapy.
Time frame: 12 Weeks
Change in Forced Expiratory Volume in one second (FEV1).
Change from baseline in FEV1 at 24 Weeks following completion of therapy
Time frame: 24 Weeks
Change in Forced Vital Capacity (FVC)
Change from baseline in FVC at 12 and 24 weeks following completion of therapy.
Time frame: 12 Weeks and 24 Weeks
Change in ratio of Residual Volume to Total Lung Capacity (RV/TLC)
Change from baseline in RV/TLC ratio at 24 weeks following completion of therapy.
Time frame: 24 Weeks
Change in distance walked in six minutes (6MWT)
Change from baseline in 6MWT distance at 24 weeks following completion of therapy.
Time frame: 24 Weeks
Change in Medical Research Council Dyspnea (MRCD) score
Change from baseline in MRCD score at 24 weeks following completion of therapy
Time frame: 24 Weeks
Change in health related quality of life assessment (St. George's Respiratory Questionnaire)(SGRQ)
Change from baseline in disease-specific health related quality of life assessment (SGRQ) at 24 weeks following completion of therapy.
Time frame: 24 Weeks
Change in Collateral Ventilation
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Change from baseline in collateral ventilation at 24 weeks following completion of therapy as measured by the Chartis System.
Time frame: 24 Weeks
Unanticipated Serious Adverse Device Effects (USADEs)
Record of any/all USADEs up to 24 weeks follwoing completion of therapy.
Time frame: 24 Week