Multicenter, randomized, assessor-blinded controlled study of safety and effectiveness of the PneumRx, Inc. RePneu Lung Volume Reduction Coil (RePneu LVRC) System
This will be a prospective, multicenter, randomized, assessor-blinded, controlled study comparing outcomes between the LVRC and Control Groups. Subjects will be block randomized in an LVRC (Treatment) to Control ratio of 1:1. The randomization will be stratified by homogeneous versus heterogeneous emphysema, to support a balance of patients with differing heterogeneity in both the LVRC and Control Groups.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
315
The LVRC group will undergo two bronchoscopic sessions under general or moderate sedation. During the procedure, subjects will be treated with Coils according to the Instructions for Use.
Meters: 6 Minute Walk Test - Change From Baseline to 12 Months Follow up
mean absolute change from baseline at 12 months in the 6 Minute Walk Test comparing test and control groups (median if skewed)
Time frame: baseline through 12 months follow up
Mean Percent Change in FEV1 From Baseline to 12 Months
Mean percent change in FEV1(Forced Expiratory Volume in 1 second) at 12 months (median if skewed)
Time frame: BL to 12 months
St. George's Respiratory Questionnaire (SGRQ) Mean Absolute Change From Baseline to 12 Months
mean absolute difference in SGRQ results comparing BL to 12 months, LVRC vs. Control, score is on a scale from 0 to 100, negative change will be a better outcome.
Time frame: BL to 12 months
6MWT Responder Analysis
6MWT Responder Analysis: Responder is defined as those with an improvement of greater than or equal to 25 meters
Time frame: 12 months
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University of Alabama Lung Health Center
Birmingham, Alabama, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
El Camino Hospital/Palo Alto Medical Foundation
Mountain View, California, United States
National Jewish Health
Denver, Colorado, United States
Yale University School of Medicine - Yale New Haven Hospital
New Haven, Connecticut, United States
University of Florida
Gainesville, Florida, United States
Northwestern University
Chicago, Illinois, United States
University of Illinois Hospital and Health Center
Chicago, Illinois, United States
Illinois Lung and Critical Care Institute
Peoria, Illinois, United States
Pulmonary and Critical Care Associates of Baltimore
Baltimore, Maryland, United States
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