The purpose of this study is to prospectively evaluate the safety and efficacy of the AeriSeal System in patients with advanced Non-Upper Lobe Predominant Heterogeneous Emphysema.
This is a prospective single arm study to evaluate the safety and efficacy of the AeriSeal System in patients with advanced Non-Upper Lobe Predominant Heterogeneous Emphysema.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
This is a prospective, open label, single-arm, multicenter, investigational study. Patients will receive either unilateral or bilateral AeriSeal System therapy as appropriate utilizing 20 mL/subsegment dosing at 2 to 4 subsegments.
Volume change by CT
Group mean normalized change from baseline in the volume of the treated lung lobes measured by quantitative CT at 24 weeks post-treatment (defined as the sum of volume change in all treated lobes/number of treatments).
Time frame: 28 - 30 weeks
Fraction of patients showing clinically significant improvements from baseline in one or more of the following outcomes at 24 weeks post treatment: Forced Expiratory Volume in 1 second (FEV1), Forced Vital Capacity (FVC), Medical Research Council Dyspnea
Group mean change in baseline to week 24 in:Forced Expiratory Volume in 1 second (FEV1),Forced Vital Capacity (FVC),Medical Research Council Dyspnea (MRCD), 6 Six-Minute Walk Test (6MWT), Saint George Respiratory Questionnaire (SGRQ)
Time frame: 28 - 30 weeks
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