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
  Purpose

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.


Condition Intervention Phase
Emphysema
COPD
Device: Zephyr endobronchial valve
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Sequential Endoscopic Lung Volume Reduction in Patients With Heterogeneous Lung Emphysema

Resource links provided by NLM:


Further study details as provided by Heidelberg University:

Primary Outcome Measures:
  • FEV 1 6 Minute walk test [ Time Frame: 6 months after intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety Symptom scores [ Time Frame: 6 months after intervention ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: January 2008
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Zephyr endobronchial valve
    Endobronchial valve system to redirect the airflow within the bronchial system
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

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Homogeneous emphysema
  • Pregnancy
  • PCO2 > 50 mmHg
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00613860

Contacts
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

Locations
Germany
Charite, University of Berlin Recruiting
Berlin, Germany, 10117
Contact: Christian Witt, MD, PhD    +49 (030) 450 565 022    pneumologie@charite.de   
Contact: Bernd Schmitt, MD    +49 (030) 450 565 02    pneumologie@charite.de   
Thoraxklinik, University of Heidelberg Recruiting
Heidelberg, Germany, 69190
Principal Investigator: Felix JF Herth, MD, PhD         
Medical Center Nürnberg Recruiting
Nürnberg, Germany, 90340
Contact: Joachim Ficker, MD, PHD    +49 (911) 398-2675    ficker@klinikum-nuernberg.de   
Contact: Manfred Wagner, MD    +49 (911) 398-0    Manfred.Wagner@klinikum-nuernberg.de   
Sponsors and Collaborators
Heidelberg University
Humboldt-Universität zu Berlin
Investigators
Principal Investigator: Felix JF Herth, MD, PhD Thoraxklinik, University of Heidelberg
  More Information

Publications:
Responsible Party: Prof. Felix JF Herth, MD, Phd; FCCP, Thoraxklinik, University of Heidelberg
ClinicalTrials.gov Identifier: NCT00613860     History of Changes
Other Study ID Numbers: 02/08
Study First Received: January 31, 2008
Last Updated: April 26, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Heidelberg University:
Endoscopic lung volume reduction, heterogeneous emphysema, interventional bronchoscopy

Additional relevant MeSH terms:
Emphysema
Pulmonary Emphysema
Pathologic Processes
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 02, 2014