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

Completed

• Conditions: COPD; Emphysema; 10038716

• Registration Number: NL-OMON35583
• Lead Sponsor: PneumRx, Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Safety<br /><br>Improvement in St. George's Respiratory Questionnaire (SGRQ) total score</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Differences between baseline visit and 3 month follow-up visit<br /><br>FEV1 (L)<br /><br>RV/TLC (%)<br /><br>Residual Volume (L)<br /><br>Six minutes walk test (m)<br /><br>modified Medical Research Counsil Dyspnea Scale (mMRC)<br /><br>Oxygen use </p><br>