Sequential Endoscopic Lung Volume Reduction

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2008 by Heidelberg University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Humboldt-Universität zu Berlin
Information provided by:
Heidelberg University
ClinicalTrials.gov Identifier:
NCT00613860
First received: January 31, 2008
Last updated: April 26, 2011
Last verified: January 2008

January 31, 2008
April 26, 2011
January 2008
December 2011   (final data collection date for primary outcome measure)
FEV 1 6 Minute walk test [ Time Frame: 6 months after intervention ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00613860 on ClinicalTrials.gov Archive Site
Safety Symptom scores [ Time Frame: 6 months after intervention ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Sequential Endoscopic Lung Volume Reduction
Sequential Endoscopic Lung Volume Reduction in Patients With Heterogeneous Lung Emphysema

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

Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Emphysema
  • COPD
Device: Zephyr endobronchial valve
Endobronchial valve system to redirect the airflow within the bronchial system
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
December 2011
December 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Homogeneous emphysema
  • Pregnancy
  • PCO2 > 50 mmHg
Both
40 Years to 80 Years
No
Contact: Ralf Eberhardt, ND +49-6221-396 8204 Ralf.Eberhardt@thoraxklinik-heidelberg.de
Contact: Jutta Kappes, MD +49-6221-396-8705 Jutta.Kappes@thoraxklinik-heidelberg.de
Germany
 
NCT00613860
02/08
Yes
Prof. Felix JF Herth, MD, Phd; FCCP, Thoraxklinik, University of Heidelberg
Heidelberg University
Humboldt-Universität zu Berlin
Principal Investigator: Felix JF Herth, MD, PhD Thoraxklinik, University of Heidelberg
Heidelberg University
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP