Sequential Endoscopic Lung Volume Reduction
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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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Emphysema COPD | Device: Zephyr endobronchial valve | Phase 3 |
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 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 |
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Device: Zephyr endobronchial valve
- FEV 1 6 Minute walk test [ Time Frame: 6 months after intervention ]
- Safety Symptom scores [ Time Frame: 6 months after intervention ]

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Ages Eligible for Study: | 40 Years to 80 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Heterogenous emphysema
- FEV1 < 45%
- RV > 150%
- TLC > 100%
- TLCO < 40%
Exclusion Criteria:
- Homogeneous emphysema
- Pregnancy
- PCO2 > 50 mmHg

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
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 |
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 |
Principal Investigator: | Felix JF Herth, MD, PhD | Thoraxklinik, University of Heidelberg |
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 |