Evaluation of the PneumRx, Inc. Lung Volume Reduction Coil for the Treatment of Emphysema

Boston Scientific Corporation5 sites in 2 countries36 target enrollmentJanuary 2008

ConditionsEmphysema

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Emphysema
Sponsor: Boston Scientific Corporation
Enrollment: 36
Locations: 5
Primary Endpoint: Quality of Life Assessment.
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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 invasive alternative to lung volume reduction surgery. The PneumRx LVRC is designed as an alternative to lung volume reduction surgery, potentially achieving the desired reduction in lung volume limiting the risks associated with major surgery, such as illness or death. This device is deployed through a bronchoscope and requires no incision.

Registry

clinicaltrials.gov

Start Date

January 2008

End Date

March 2012

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Boston Scientific Corporation

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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 Criteria

•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