Unilateral Versus Bilateral Endoscopic Lung Volume Reduction A Comparative Case Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Unilateral vs. Bilateral IBV Placement

Conditions
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Pulmonary Emphysema

Intervention / Treatment
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* Device: IBV Implantation
* Device: IBV Implantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age > 40 inhomogeneous emphysema FEV1 between 20-40% DLCO between 20-40% 6MWT > 150 m Exclusion Criteria: pregnant homogeneous disease FEV1 < 20%

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: bilateral<br>Treatment arm B - incomplete bilateral treatment of in total two lobes (contralateral). The study will only use Intrabronchial Valves™ | Device: IBV Implantation<br>* In severe cases of COPD even optimum treatment involving bronchodilatation with drugs, physical training and possibly oxygen therapy is unable to influence exercise capacity and the perception of dyspnoea to a sufficient extent. Given the assumption that the elastic recoil of the small airways can be improved by a reduction in lung volume and pulmonary function overall by more ergonomic breathing mechanics and diaphragm function, various endoscopic procedures for lung volume reduction are available. Here one of the most advanced techniques is the implantation of intrabronchial valves. The one-way mechanism of this valve allows air to escape from the downstream lung segment without any influx of new air during inspiration<br>* Other names: Spiration IBV;|
| Active Comparator: unilateral<br>Treatment arm A - unilateral treatment with complete closure of the worst lobe of the lungs | Device: IBV Implantation<br>* In severe cases of COPD even optimum treatment involving bronchodilatation with drugs, physical training and possibly oxygen therapy is unable to influence exercise capacity and the perception of dyspnoea to a sufficient extent. Given the assumption that the elastic recoil of the small airways can be improved by a reduction in lung volume and pulmonary function overall by more ergonomic breathing mechanics and diaphragm function, various endoscopic procedures for lung volume reduction are available. Here one of the most advanced techniques is the implantation of intrabronchial valves. The one-way mechanism of this valve allows air to escape from the downstream lung segment without any influx of new air during inspiration<br>* Other names: Spiration IBV;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in pulmonary function (FEV1) 6-minute walking test |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endoscopic lung volume reduction, emphysema, COPD, Patients with bilateral heterogeneous pulmonary emphysema