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 : March 19, 2021
|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 - Change From Baseline to 12 Months Follow up [ 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 (median if skewed)
- Mean Percent Change in FEV1 From Baseline to 12 Months [ Time Frame: BL to 12 months ]Mean percent change in FEV1(Forced Expiratory Volume in 1 second) at 12 months (median if skewed)
- St. George's Respiratory Questionnaire (SGRQ) Mean Absolute Change From Baseline to 12 Months [ Time Frame: BL 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.
- 6MWT Responder Analysis [ Time Frame: 12 months ]6MWT Responder Analysis: Responder is defined as those with an improvement of greater than or equal to 25 meters
- SGRQ Responder Analysis [ Time Frame: 12 months ]SGRQ Responder Analysis: Responder defined as those with an improvement greater than or equal to 4 points
- Residual Volume (RV) Mean Absolute Difference in RV From Baseline to 12 Months [ Time Frame: 12 months ]Mean absolute difference in RV results measured using plethysmography, comparing BL to 12 months, LVRC vs. Control
- RV/TLC Mean Absolute Difference From Baseline to 12 Months [ Time Frame: 12 months ]Mean absolute difference in RV/TLC (residual volume/total lung capacity - a measure done during lung function testing where residual volume is air left over in lung after completely breathing out and total lung capacity is how much air the lung can breathe in) results measured using plethysmography, comparing BL to 12 months, LVRC vs. Control
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|