Bronchoscopic Lung Volume reduction with endobronchial valves using best responder criteria in patients with severe COPD

Phase 3

Completed

• Conditions: COPD Emphysema; 10038716

• Registration Number: NL-OMON39131
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 68

Inclusion Criteria

Heterogeneous emphysema on CT scan
Complete fissures on CT scan
Signed Informed Consen

Exclusion Criteria

Hypercapnia defined by PaCO2>8.0 kPa, or hypoxemia defined by PaO2<6.0kPa, both measured on room air.
6MWT <140 meters
Previous LVR-surgery, lung transplantation or lobectomy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Clinical Evaluation: a clinical significant improvement of FVC, FEV1 and 6<br /><br>minutes walk test.<br /><br><br /><br>Economic Evaluation: total costs of the bronchoscopic lung volume reduction<br /><br>compared to usual care and (historical) costs of LVRS.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Quality of life (measured by SGRQ, CCQ)<br /><br>Target lobar volume change on a full inspiratory thin slice CT scan</p><br>