NL-OMON35583
Completed
Not Applicable
Evaluation of the PneumRx, Inc. Lung Volume Reduction Device for the Treatment of Emphysema. - LVR-Coil Safety Study
PneumRx, Inc0 sites20 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- COPD
- Sponsor
- PneumRx, Inc
- Enrollment
- 20
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Emphysema on HRCT\-thorax
- •Post\-bronchodilator FEV1 \< 45% predicted
- •Total Lung Capacity \> 100% predicted
- •mMRC dyspnea score \>2
- •Stopped smoking \> 8 weeks
Exclusion Criteria
- •History of recurrent respiratory infections and/or bronchiectasis
- •Cardiovasculair pathology
- •Inability to walk \> 140 meters in 6 minutes
- •Giant bullae (\> 1/3 lung volume)
- •Patient is taking \> 20 mg prednisone (or similar steroid) daily
- •Patient has evidence of other disease that may compromise survival (such as lung cancer, renal failure etc)
Outcomes
Primary Outcomes
Not specified
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