Sequential Endoscopic Lung Volume Reduction

Heidelberg University

Status and phase: Withdrawn; Phase 3

Conditions: Emphysema; COPD

Treatments: Device: Zephyr endobronchial valve

Study type: Interventional

Funder types: Other

Identifiers

NCT00613860

02/08

Details and patient eligibility

About

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.

Full 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

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Heterogenous emphysema
• FEV1 < 45%
• RV > 150%
• TLC > 100%
• TLCO < 40%

Exclusion criteria

• Homogeneous emphysema
• Pregnancy
• PCO2 > 50 mmHg

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)