Unilateral Versus Bilateral Endoscopic Lung Volume Reduction A Comparative Case Study
Phase 2
- Conditions
- Pulmonary Emphysema
- Interventions
- Device: IBV Implantation
- 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.
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
- Arm && Interventions
Group Intervention Description bilateral IBV Implantation Treatment arm B - incomplete bilateral treatment of in total two lobes (contralateral). The study will only use Intrabronchial Valves™ unilateral IBV Implantation Treatment arm A - unilateral treatment with complete closure of the worst lobe of the lungs
- 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