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Trial record 1 of 2 for:    renew copd
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Lung Volume Reduction Coil Treatment in Patients With Emphysema (RENEW) Study (RENEW)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01608490
First Posted: May 31, 2012
Last Update Posted: June 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
PneumRx, Inc.
Results First Submitted: April 25, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Emphysema
Intervention: Device: RePneu Lung Volume Reduction Coil System

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

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.

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.

Participant Flow:   Overall Study
    RePneu Lung Volume Reduction Coil System   Control Arm is Standard Medical Care
STARTED   158   157 
COMPLETED   158   157 
NOT COMPLETED   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

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.

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.
Total Total of all reporting groups

Baseline Measures
   RePneu Lung Volume Reduction Coil System   Control Arm is Standard Medical Care   Total 
Overall Participants Analyzed 
[Units: Participants]
 158   157   315 
Age 
[Units: Years]
Mean (Standard Deviation)
 63.4  (8.05)   64.3  (7.76)   63.9  (7.9) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      86  54.4%      79  50.3%      165  52.4% 
Male      72  45.6%      78  49.7%      150  47.6% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      0   0.0%      0   0.0%      0   0.0% 
Not Hispanic or Latino      157  99.4%      157 100.0%      314  99.7% 
Unknown or Not Reported      1   0.6%      0   0.0%      1   0.3% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Meters: 6 Minute Walk Test   [ Time Frame: baseline through 12 months follow up ]

2.  Secondary:   Mean Percent Change in FEV1   [ Time Frame: BL to 12 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Ashley Burns
Organization: PneumRx
phone: +1 650 625 8910 ext 6122
e-mail: Ashley.Burns@btgplc.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: PneumRx, Inc.
ClinicalTrials.gov Identifier: NCT01608490     History of Changes
Other Study ID Numbers: CLN0009
First Submitted: May 26, 2012
First Posted: May 31, 2012
Results First Submitted: April 25, 2017
Results First Posted: June 27, 2017
Last Update Posted: June 27, 2017