Sequential Endoscopic Lung Volume Reduction

Phase 3

Withdrawn

• Conditions: COPD; Emphysema

• Registration Number: NCT00613860
• Lead Sponsor: Heidelberg University

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

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-01-31
• Study First Submitted QC: 2008-02-12
• Study First Posted: 2008-02-13
• Primary Completion: 2011-12
• Study Completion: 2012-04
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-30
• Last Update Posted: 2022-09-02

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

• Homogeneous emphysema
• Pregnancy
• PCO2 > 50 mmHg

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
FEV 1 6 Minute walk test	6 months after intervention

Secondary Outcome Measures

Name	Time	Method
Safety Symptom scores	6 months after intervention

Trial Locations

Locations (3)

Charite, University of Berlin; 🇩🇪 Berlin, Germany

Thoraxklinik, University of Heidelberg; 🇩🇪 Heidelberg, Germany

Medical Center Nürnberg; 🇩🇪 Nürnberg, Germany