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Implantation of Endobronchial Valves Versus Intrabronchial Valves in Patients With Severe Heterogeneous Emphysema

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ClinicalTrials.gov Identifier: NCT01457833
Recruitment Status : Unknown
Verified October 2011 by Felix JF Herth, University of Heidelberg.
Recruitment status was:  Recruiting
First Posted : October 24, 2011
Last Update Posted : October 24, 2011
Sponsor:
Information provided by (Responsible Party):
Felix JF Herth, University of Heidelberg

Brief Summary:
Patients with advanced heterogeneous emphysema experience improvement in clinical outcomes in the same way following either implantation of endobronchial valves or intrabronchial valves.

Condition or disease Intervention/treatment Phase
Pulmonary Emphysema Device: EBV implantation Device: IBV implantation Phase 2 Phase 3

Detailed Description:
Patient enrollment and data acquisition is to be carried out on a prospective basis. It is planned to enroll a total of 50 patients with advanced heterogeneous emphysema. After decision to undertake endoscopic lung volume reduction by valve implantation patients will be randomised to two treatment arms. 25 patients receive unilateral IBV treatment or unilateral EBV treatment in each case. All patients will undergo treatment at one study centre in Heidelberg.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Endoscopic Lung Volume Reduction by Implantation of Endobronchial Valves (EBV) vs. Intrabronchial Valves (IBV) in Patients With Severe Heterogeneous Emphysema
Study Start Date : August 2011
Estimated Primary Completion Date : May 2012
Estimated Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Emphysema
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Endobronchial valves (EBV)
Complete occlusion of one emphysematous destroyed lobe by implantation of endobronchial valves
Device: EBV implantation
In severe cases of COPD even optimum treatment involving bronchodilatation with drugs, physical training and possibly oxygen therapy is unable to influence exercise capacity and the perception of dyspnoea to a sufficient extent. Given the assumption that the elastic recoil of the small airways can be improved by a reduction in lung volume and pulmonary function overall by more ergonomic breathing mechanics and diaphragm function, various endoscopic procedures for lung volume reduction are available. The most advanced technique is the implantation of valves. The one-way mechanism of these valves allows air to be expelled during exspiration without any influx of air during inspiration.
Other Name: (Zephyr EBV)
Active Comparator: Intrabronchial valves (IBV)
Complete occlusion of one emphysematous destroyed lobe by implantation of intrabronchial valves
Device: IBV implantation
In severe cases of COPD even optimum treatment involving bronchodilatation with drugs, physical training and possibly oxygen therapy is unable to influence exercise capacity and the perception of dyspnoea to a sufficient extent. Given the assumption that the elastic recoil of the small airways can be improved by a reduction in lung volume and pulmonary function overall by more ergonomic breathing mechanics and diaphragm function, various endoscopic procedures for lung volume reduction are available. The most advanced technique is the implantation of valves. The one-way mechanism of these valves allows air to be expelled during exspiration without any influx of air during inspiration.
Other Name: (Spiration IBV)



Primary Outcome Measures :
  1. Improvement in pulmonary function (FEV1 and RV/TLC) [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Number of severe adverse events [ Time Frame: 6 months ]
  2. Evaluation of valve migration rate [ Time Frame: 6 months ]
  3. Average changes in pulmonary function (FEV1, IVC, RV, TLC, RV/TLC) [ Time Frame: 6 months ]
  4. Average changes in 6-minute-walk-distance [ Time Frame: 6 months ]


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Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • pulmonary function: FEV1 < 45 %, RV > 150 %, TLC > 100 %
  • heterogeneous emphysema

Exclusion Criteria:

  • homogeneous emphysema
  • significant bronchiectasis
  • severe concomitant diseases
  • pregnancy

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): NCT01457833


Contacts
Contact: Daniela Gompelmann, MD +49(0)62213968087 daniela.gompelmann@thoraxklinik-heidelberg.de
Contact: Felix JF Herth, MD +49(0)62213961200 felix.herth@thoraxklinik-heidelberg.de

Locations
Germany
Thoraxklinik Heidelberg Recruiting
Heidelberg, Germany, 69126
Contact: Daniela Gompelmann, MD    +49(0)62213968087    daniela.gompelmann@thoraxklinik-heidelberg.de   
Principal Investigator: Daniela Gompelmann, MD         
Sponsors and Collaborators
Heidelberg University

Responsible Party: Felix JF Herth, Professor MD, University of Heidelberg
ClinicalTrials.gov Identifier: NCT01457833     History of Changes
Other Study ID Numbers: Protokoll E1.0-23.05.2011
First Posted: October 24, 2011    Key Record Dates
Last Update Posted: October 24, 2011
Last Verified: October 2011

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