This study will evaluate the effects of baseline collateral ventilation status on outcomes following treatment with AeriSeal System in patients with advanced upper-lobe predominant heterogenous emphysema.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
4 Subsegments treated - 2 each bilaterally
4 Subsegments treated - 2 each bilaterally
Zentralklinik Bad Berka GmbH
Bad Berka, Germany
Charite Campus Virchow-Klinikum
Berlin, Germany
Klinikum Coburg
Coburg, Germany
Change from baseline in group mean post bronchodilator Forced Exhalation Volume in one second (FEV1)
Time frame: 24 Weeks
Change from Baseline in group mean 6 Minute Walk Test (6MWT) distance
Time frame: 24 Weeks
Change from baseline in group mean health related quality of life
Change from baseline in group mean health related quality of life, measured in terms of St. George's Respiratory Questionnaire (SGRQ) total domain score
Time frame: 24 Weeks
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Klinikum Donaustauf
Donaustauf, Germany
Asklepios Fachkliniken Muenchen - Gauting
Gauting, Germany
Universitatsklinikum Halle
Halle, Germany
Asklepios Klinik Hamburg-Harburg
Hamburg, Germany
Thoraxklinik am Uniklinikum Heidelberg
Heidelberg, Germany
Sana Kliniken Luebeck
Lübeck, Germany
Medizinische Klinik und Poliklinik Grosshadern
München, Germany
...and 3 more locations