Status:
COMPLETED
Evaluation of the PneumRx Lung Volume Reduction Coil to Treat Emphysema
Lead Sponsor:
Boston Scientific Corporation
Collaborating Sponsors:
PneumRx, Inc.
Conditions:
Emphysema
Eligibility:
All Genders
35-100 years
Phase:
NA
Brief Summary
The objective of this study is to demonstrate the safety of the PneumRx Lung Volume Reduction Coil (LVRC) in a population of patients with emphysema. The PneumRx, Inc. LVRC is a used as a less invasiv...
Eligibility Criteria
Inclusion
- Patient \> 35 years of age
- unilateral or bilateral emphysema
- Patient has stopped smoking for a minimum of 8 weeks
- Read, understood and signed the Informed Consent form
Exclusion
- Patient has a history of recurrent clinically significant respiratory infection
- Patient has an inability to walk \>140 meters
- Patient has evidence of other disease that may compromise survival such as lung cancer, renal failure, etc
- Patient is pregnant or lactating
- Patient has clinically significant bronchiectasis
- Patient has had previous LVR surgery, lung transplant or lobectomy
- Patient has been involved in other pulmonary drug studies with 30 days prior to this study
- Patient has other disease that would interfere with completion of study, follow up assessments or that would adversely affect outcomes
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT01220908
Start Date
January 1 2008
End Date
March 1 2012
Last Update
May 11 2023
Active Locations (5)
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1
Klinikum Donaustauf
Donaustauf, Germany
2
Asklepios
Gauting, Germany
3
Pneumology and Respiratory Care Medicine Thoraxklinik, University of Heidelberg
Heidelberg, Germany
4
Lungenklinik
Hemer, Germany