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

Arm | Intervention/treatment |
---|---|
Active Comparator: Endobronchial valves (EBV)
Complete occlusion of one emphysematous destroyed lobe by implantation of endobronchial valves
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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)
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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)
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- Improvement in pulmonary function (FEV1 and RV/TLC) [ Time Frame: 6 months ]
- Number of severe adverse events [ Time Frame: 6 months ]
- Evaluation of valve migration rate [ Time Frame: 6 months ]
- Average changes in pulmonary function (FEV1, IVC, RV, TLC, RV/TLC) [ Time Frame: 6 months ]
- 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 |
Inclusion Criteria:
- pulmonary function: FEV1 < 45 %, RV > 150 %, TLC > 100 %
- heterogeneous emphysema
Exclusion Criteria:
- homogeneous emphysema
- significant bronchiectasis
- severe concomitant diseases
- pregnancy

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