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Clinical Trial Summary

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


Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00995852
Study type Interventional
Source Heidelberg University
Contact Felix JF Herth, MD
Phone +49 6221 396
Email Felix.Herth@thoraxklinik-heidelberg.de
Status Recruiting
Phase Phase 2/Phase 3
Start date September 2009
Completion date May 2011

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