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Sequential Endoscopic Lung Volume Reduction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00613860
Recruitment Status : Unknown
Verified January 2008 by Heidelberg University.
Recruitment status was:  Recruiting
First Posted : February 13, 2008
Last Update Posted : April 27, 2011
Sponsor:
Collaborator:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Emphysema COPD Device: Zephyr endobronchial valve Phase 3

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sequential Endoscopic Lung Volume Reduction in Patients With Heterogeneous Lung Emphysema
Study Start Date : January 2008
Estimated Primary Completion Date : December 2011
Estimated Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Emphysema Endoscopy
U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Device: Zephyr endobronchial valve
    Endobronchial valve system to redirect the airflow within the bronchial system

Outcome Measures

Primary Outcome Measures :
  1. FEV 1 6 Minute walk test [ Time Frame: 6 months after intervention ]

Secondary Outcome Measures :
  1. Safety Symptom scores [ Time Frame: 6 months after intervention ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: February 13, 2008    Key Record Dates
Last Update Posted: April 27, 2011
Last Verified: January 2008

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