Status:
COMPLETED
Evaluation of Physiologic Parameters to Study the Mechanism of Action of the Lung Volume Reduction Coil in Subjects With Homogeneous Emphysema
Lead Sponsor:
Boston Scientific Corporation
Collaborating Sponsors:
PneumRx, Inc.
Conditions:
Emphysema
Eligibility:
All Genders
35+ years
Phase:
PHASE2
PHASE3
Brief Summary
The PneumRx Lung Volume Reduction Coil (LVRC) has been shown to effectively improve quality of life, exercise capacity, and static lung volumes, in patients with emphysema. The mechanism of action for...
Eligibility Criteria
Inclusion
- Subject \> 35 years of age CT scan indicates homogeneous emphysema Subject has stopped smoking for a minimum of 6 months prior Subject (and legal guardian if applicable) read, understood and signed the Informed Consent form
Exclusion
- Subject has a history of recurrent clinically significant respiratory infection Subject has uncontrolled pulmonary hypertension Subject has evidence of other disease that may compromise survival such as lung cancer, renal failure, etc Subject is pregnant or lactating Subject has an inability to tolerate bronchoscopy Subject has clinically significant bronchiectasis Subject has giant bullae Subject has had previous LVR surgery, lung transplant or lobectomy Subject has been involved in other pulmonary drug studies with 30 days prior Subject has other condition that would interfere with completion of study, follow up assessments or that would adversely affect outcomes
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01421082
Start Date
February 1 2012
End Date
March 1 2013
Last Update
July 16 2021
Active Locations (1)
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1
University Medical Center Groningen - UMCG
Groningen, The Netherlands, Netherlands, 9700 RB