Unilateral Versus Bilateral Endoscopic Lung Volume Reduction A Comparative Case Study

Phase 2

• Conditions: Pulmonary Emphysema

• Registration Number: NCT00995852
• Lead Sponsor: Heidelberg University

Brief Summary

Patients with bilateral heterogeneous pulmonary emphysema benefit to differing degrees from unilateral ELVR with complete lobe closure in comparison with incomplete bilateral treatment.

Detailed Description

Patient enrolment and data acquisition is to be carried out on a prospective basis. It is planned to enrol a total of 20 patients with bilateral heterogeneous pulmonary emphysema. All patients will undergo treatment at one study centre in Heidelberg. Patients will be considered for both unilateral and bilateral treatment with intrabronchial valves (IBV) on the basis of their emphysema distribution. Patients will be randomised to two treatment arms. 10 patients receive unilateral or bilateral treatment in each case.

Study Timeline

• Study Start: 2009-09
• Status Verified: 2009-10
• Study First Submitted: 2009-10-14
• Study First Submitted QC: 2009-10-14
• Study First Posted: 2009-10-15
• Last Update Submitted: 2011-04-26
• Last Update Posted: 2011-04-27
• Primary Completion: 2011-05
• Study Completion: 2011-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• age > 40 inhomogeneous emphysema FEV1 between 20-40% DLCO between 20-40% 6MWT > 150 m

Exclusion Criteria

• pregnant homogeneous disease FEV1 < 20%

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Improvement in pulmonary function (FEV1) 6-minute walking test	3 months

Secondary Outcome Measures

Name	Time	Method
Number of major complications(SAE)	3 months
Evaluation of the IBV migration rate	3 months
Average changes in quality of life (SGRQ)	3 months
Average changes in pulmonary function (FEV1, IVC, RV, TLC, RV/TLC)	3 months

Trial Locations

Locations (1)

Thoraxklinik Heidelberg; 🇩🇪 Heidelberg, Germany