Lung Volume Reduction Coil Treatment in Patients With Emphysema (RENEW) Study (RENEW)
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|ClinicalTrials.gov Identifier: NCT01608490|
Recruitment Status : Terminated (FDA approval of supplementation to IDE to terminate subject long term follow up)
First Posted : May 31, 2012
Results First Posted : June 27, 2017
Last Update Posted : August 21, 2019
|Condition or disease||Intervention/treatment||Phase|
|Emphysema||Device: RePneu Lung Volume Reduction Coil System||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||315 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||One group received standard of care and LVRC and the control group received only standard of care.|
|Masking:||None (Open Label)|
|Official Title:||Lung Volume Reduction Coil Treatment in Patients With Emphysema (RENEW) Study|
|Study Start Date :||October 2012|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||July 26, 2019|
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.
- Meters: 6 Minute Walk Test [ Time Frame: baseline through 12 months follow up ]mean absolute change from baseline at 12 months in the 6 Minute Walk Test comparing test and control groups
- Mean Percent Change in FEV1 [ Time Frame: BL to 12 months ]Mean percent change in FEV1 at 12 months
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01608490
|Principal Investigator:||Charlie Strange, MD||Medical University of South Carolina|