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

Sponsor
Heidelberg University (Other)
Overall Status
Completed
CT.gov ID
NCT01457833
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
9
Duration (Months)
6.7
Patients Per Site Per Month

Study Details

Study Description

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
  • Device: EBV implantation
  • Device: IBV implantation
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
60 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 :
Aug 1, 2011
Actual Primary Completion Date :
May 1, 2012
Actual Study Completion Date :
May 1, 2012

Arms and Interventions

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 Names:
  • (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 Names:
  • (Spiration IBV)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Improvement in pulmonary function (FEV1 and RV/TLC) [6 months]

    Secondary Outcome Measures

    1. Number of severe adverse events [6 months]

    2. Evaluation of valve migration rate [6 months]

    3. Average changes in pulmonary function (FEV1, IVC, RV, TLC, RV/TLC) [6 months]

    4. Average changes in 6-minute-walk-distance [6 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

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

    • heterogeneous emphysema

    Exclusion Criteria:

    • homogeneous emphysema

    • significant bronchiectasis

    • severe concomitant diseases

    • pregnancy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Thoraxklinik Heidelberg Heidelberg Germany 69126

    Sponsors and Collaborators

    • Heidelberg University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Felix JF Herth, Professor MD, Heidelberg University
    ClinicalTrials.gov Identifier:
    NCT01457833
    Other Study ID Numbers:
    • Protokoll E1.0-23.05.2011
    First Posted:
    Oct 24, 2011
    Last Update Posted:
    Jul 7, 2022
    Last Verified:
    Jul 1, 2022
    Additional relevant MeSH terms:
    Pulmonary Emphysema
    Emphysema

    Study Results

    No Results Posted as of Jul 7, 2022