The objective of this study is to demonstrate the safety and performance of the PneumRx, Inc. Lung Volume Reduction Coil (LVRC) in a population of patients with emphysema. The PneumRx, Inc. LVRC is used as a less invasive alternative to lung volume reduction surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
47
Lung Volume Reduction Coil (LVRC)
Standard of Care
Unnamed facility
Glasgow, United Kingdom
Chelsea and Westminster Hospital
London, United Kingdom
Unnamed facility
Manchester, United Kingdom
St. George's Respiratory Questionnaire (SGRQ)
The primary efficacy endpoint will be the difference between treatment and control groups in the change in St. George's Respiratory Questionnaire (SGRQ) from Baseline (Pre-Treatment Visit) to the three month Follow-Up Visit.
Time frame: three month Follow-Up Visit
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