Sequential Endoscopic Lung Volume Reduction

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

Patients with heterogenous emphysema benefits from endoscopic lung volume reduction. Until now the technique is limited to one lobe. In case of collateral ventilation patients show no improvement. Between upper and middle lobe exists the highest collateral flow. The trial examine the hypothesis, that sequential ELVR help especially those patients, which have no benefit after lobar exclusion.

Condition or disease	Intervention/treatment	Phase
Emphysema; COPD	Device: Zephyr endobronchial valve	Phase 3

Detailed Description:

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 Design

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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

Arms and Interventions

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Intervention Details:

Device: Zephyr endobronchial valve
Endobronchial valve system to redirect the airflow within the bronchial system

Outcome Measures

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Primary Outcome Measures :

1. FEV 1 6 Minute walk test [ Time Frame: 6 months after intervention ]

Secondary Outcome Measures :

1. Safety Symptom scores [ Time Frame: 6 months after intervention ]

Eligibility Criteria

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Ages Eligible for Study:	40 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Heterogenous emphysema
• FEV1 < 45%
• RV > 150%
• TLC > 100%
• TLCO < 40%

Exclusion Criteria:

• Homogeneous emphysema
• Pregnancy
• PCO2 > 50 mmHg

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

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

Locations

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

Sponsors and Collaborators

Heidelberg University

Humboldt-Universität zu Berlin

Investigators

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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Strange C, Herth FJ, Kovitz KL, McLennan G, Ernst A, Goldin J, Noppen M, Criner GJ, Sciurba FC; VENT Study Group. Design of the Endobronchial Valve for Emphysema Palliation Trial (VENT): a non-surgical method of lung volume reduction. BMC Pulm Med. 2007 Jul 3;7:10.

de Oliveira HG, Macedo-Neto AV, John AB, Jungblut S, Prolla JC, Menna-Barreto SS, Fortis EA. Transbronchoscopic pulmonary emphysema treatment: 1-month to 24-month endoscopic follow-up. Chest. 2006 Jul;130(1):190-9.

Venuta F, de Giacomo T, Rendina EA, Ciccone AM, Diso D, Perrone A, Parola D, Anile M, Coloni GF. Bronchoscopic lung-volume reduction with one-way valves in patients with heterogenous emphysema. Ann Thorac Surg. 2005 Feb;79(2):411-6; discussion 416-7.

Yim AP, Hwong TM, Lee TW, Li WW, Lam S, Yeung TK, Hui DS, Ko FW, Sihoe AD, Thung KH, Arifi AA. Early results of endoscopic lung volume reduction for emphysema. J Thorac Cardiovasc Surg. 2004 Jun;127(6):1564-73.

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
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