This study will look at outcomes between Endobronchial Coil Treatment and Control groups in patients with severe heterogeneous and or homogeneous emphysema.
This will be a prospective, multicenter, randomized, controlled study comparing outcomes between the Endobronchial Coil and Control Groups. Subjects will be block randomized in a Treatment to Control ratio of 2:1. The randomization will be stratified by site and homogeneous versus heterogeneous emphysema, to support a balance of patients with differing heterogeneity in both the Treatment and Control Groups
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Endobronchial Coil implants
Ludwig Boltzmann Institut Fur COPD und pneumologische Epidemologie
Vienna, Austria
CHU Grenoble
Grenoble, France
Percent Change in FEV1 at 6 Months
Percent change in FEV1
Time frame: 6 months
Absolute Change in SGRQ Score at 6 Months
Change in SGRQ score - St. George Respiratory Questionnaire from 0 to 100, higher score indicating more limitations (worse), increase in score indicating worse outcome, decrease in score indicating improvement
Time frame: 6 months
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...and 9 more locations