COPD, Emphysema
Conditions
Keywords
Endoscopic lung volume reduction, heterogeneous emphysema, interventional bronchoscopy
Brief summary
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.
Detailed description
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
Interventions
Endobronchial valve system to redirect the airflow within the bronchial system
Sponsors
Humboldt-Universität zu Berlin
Heidelberg University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Heterogenous emphysema * FEV1 \< 45% * RV \> 150% * TLC \> 100% * TLCO \< 40%
Exclusion criteria
* Homogeneous emphysema * Pregnancy * PCO2 \> 50 mmHg
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| FEV 1 6 Minute walk test | 6 months after intervention |
Secondary
| Measure | Time frame |
|---|---|
| Safety Symptom scores | 6 months after intervention |
Countries
Germany
Outcome results
None listed