A Non-randomized Study to Evaluate the Safety and Performance of the Portaero Pneumostoma System in Patients with Severe Emphysema and Hyperinflation of the Lung
Phase 2
Completed
- Conditions
- COPDEmphysema10038716
- Registration Number
- NL-OMON34355
- Lead Sponsor
- Portaero Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 7
Inclusion Criteria
- HRCT consistent with severe emphysema grade >2/4
- FEV1 < 45% predicted
- Patient with hyperinflation defined as RV > 150% predicted, TLC > 100% predicted
- Arterial Bloodgas PaO2 > 45 mmHg and PaCO < 60 mmHg
- Stopped smoking and with a smoking history of > 20 pack years
Exclusion Criteria
- History of recurrent respiratory infections
- Cardiovasculair pathology
- Inability to walk > 140 meters in 6 minutes
- Giant bullae (> 1/3 lung volume)
- Patient is taking > 10 mg prednisone (or similar steroid) daily
- Patient has evidence of other disease that may compromise survival (such as lung cancer)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method