Sequential Endoscopic Lung Volume Reduction

Heidelberg University

Overview

Patients with heterogenous emphysema benefits from endoscopic lung volume reduction. Until now the technique is limited to one lobe. In case of collateral ventilation patients show no improvement. Between upper and middle lobe exists the highest collateral flow. The trial examine the hypothesis, that sequential ELVR help especially those patients, which have no benefit after lobar exclusion.

Patients with heterogenous emphysema undergo ELVR, target lobe is the upper lobe right. After 6 weeks the middle lobe will be block too. Follow-up period 6 months Primary end points: FEV 1, 6-Minute walk test Secondary endpoints. Safety, Symptom scores Number of patients planned 30

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Conditions

Emphysema COPD

Interventions

Zephyr endobronchial valveDEVICE

Endobronchial valve system to redirect the airflow within the bronchial system

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Heterogenous emphysema * FEV1 \< 45% * RV \> 150% * TLC \> 100% * TLCO \< 40% Exclusion Criteria: * Homogeneous emphysema * Pregnancy * PCO2 \> 50 mmHg

Locations (3)

Charite, University of Berlin

Berlin, Germany

Thoraxklinik, University of Heidelberg

Heidelberg, Germany

Medical Center Nürnberg

Nuremberg, Germany

Outcomes

Primary Outcomes

FEV 1 6 Minute walk test

Time frame: 6 months after intervention

Secondary Outcomes

Safety Symptom scores

Time frame: 6 months after intervention

Data from ClinicalTrials.gov

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