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

This study is currently recruiting participants.
Verified October 2011 by University of Heidelberg
Sponsor:
Information provided by (Responsible Party):
Felix JF Herth, University of Heidelberg
ClinicalTrials.gov Identifier:
NCT01457833
First received: October 19, 2011
Last updated: October 21, 2011
Last verified: October 2011
History of Changes

October 19, 2011
October 21, 2011
August 2011
May 2012   (final data collection date for primary outcome measure)
Improvement in pulmonary function (FEV1 and RV/TLC) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01457833 on ClinicalTrials.gov Archive Site
  • Number of severe adverse events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Evaluation of valve migration rate [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Average changes in pulmonary function (FEV1, IVC, RV, TLC, RV/TLC) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Average changes in 6-minute-walk-distance [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
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Not Provided
 
Implantation of Endobronchial Valves Versus Intrabronchial Valves in Patients With Severe Heterogeneous Emphysema
Endoscopic Lung Volume Reduction by Implantation of Endobronchial Valves (EBV) vs. Intrabronchial Valves (IBV) in Patients With Severe Heterogeneous Emphysema

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

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.
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Pulmonary Emphysema
  • 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)
  • 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)
  • Active Comparator: Endobronchial valves (EBV)
    Complete occlusion of one emphysematous destroyed lobe by implantation of endobronchial valves
    Intervention: Device: EBV implantation
  • Active Comparator: Intrabronchial valves (IBV)
    Complete occlusion of one emphysematous destroyed lobe by implantation of intrabronchial valves
    Intervention: Device: IBV implantation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
May 2012
May 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • homogeneous emphysema
  • significant bronchiectasis
  • severe concomitant diseases
  • pregnancy
Both
30 Years and older
No
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
Germany
 
NCT01457833
Protokoll E1.0-23.05.2011
Not Provided
Felix JF Herth, University of Heidelberg
University of Heidelberg
Not Provided
Not Provided
University of Heidelberg
October 2011

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