Lung Volume Reduction Coil Treatment in Patients With Emphysema (RENEW) Study
Multicenter, randomized, assessor-blinded controlled study of safety and effectiveness of the PneumRx, Inc. RePneu Lung Volume Reduction Coil (RePneu LVRC) System
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Lung Volume Reduction Coil Treatment in Patients With Emphysema (RENEW) Study|
- mean absolute change from baseline at 12 months in the 6 Minute Walk Test comparing test and control groups [ Time Frame: baseline through 12 months follow up ] [ Designated as safety issue: No ]
- Mean absolute difference in SGRQ, 6MWT (responder analysis) and mean percent change in FEV1 comparing BL to 12 months, between Treatment arms. [ Time Frame: BL to 12 months ] [ Designated as safety issue: No ]
|Study Start Date:||October 2012|
|Estimated Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
Experimental: RePneu Lung Volume Reduction Coil System
The RePneu Lung Volume Reduction Coil System is an implantable device, delivered through a fiber-optic bronchoscope. This is a two part system that consists of 1) sterile Nitinol Coils and 2) a sterile, disposable, single-use (single-patient) Delivery System consisting of a Guidewire, Catheter, Cartridge, and Forceps.
Device: RePneu Lung Volume Reduction Coil System
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.
No Intervention: Control arm is standard medical care
The Control Group will not undergo any bronchoscopies for Coil placement and will not receive prophylactic antibiotics or steroids before and after 'treatment' or chest x-rays in connection with the 'treatment' visits. The frequency of visits to the Study Doctor or designee will be similar to the LVRC Group.
This will be a prospective, multicenter, randomized, 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.
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|Principal Investigator:||Charlie Strange, MD||Medical University of South Carolina|