Evaluation of the PneumRx, Inc. Lung Volume Reduction Device for the Treatment of Subjects with Homogeneous Emphysema
Phase 2
Completed
- Conditions
- COPDEmphysema10038716
- Registration Number
- NL-OMON35800
- Lead Sponsor
- PneumRx
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
Inclusion Criteria
Homogeneous emphysema on CT-thorax
Post-bronchodilator FEV1 < 35% predicted
Total Lung Capacity > 120% predicted
Residual Volume > 225% predicted
mMRC dyspnea score >2
Stopped smoking > 6 months
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 > 20 mg prednisone (or similar steroid) daily
Patient has evidence of other disease that may compromise survival (such as lung cancer, renal failure etc)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p> Differences between baseline visit and follow-up visit Six minutes walk test<br /><br>(m) .</p><br>
- Secondary Outcome Measures
Name Time Method <p> Differences between baseline visit and 6 month follow-up visit PFT<br /><br>measurements and quality of Life parameters (questionnaires). </p><br>