Sequential Endoscopic Lung Volume Reduction

The recruitment status of this study is unknown because the information has not been verified recently.

Verified January 2008 by University of Heidelberg.
Recruitment status was Recruiting

Sponsor:

Collaborator:

Humboldt-Universität zu Berlin

Information provided by:

University of Heidelberg

ClinicalTrials.gov Identifier:

NCT00613860

First received: January 31, 2008

Last updated: April 26, 2011

Last verified: January 2008

History of Changes

Purpose

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	Intervention	Phase
Emphysema COPD	Device: Zephyr endobronchial valve	Phase 3

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Sequential Endoscopic Lung Volume Reduction in Patients With Heterogeneous Lung Emphysema

Resource links provided by NLM:

MedlinePlus related topics: Emphysema Endoscopy

U.S. FDA Resources

Further study details as provided by University of Heidelberg:

Primary Outcome Measures:

FEV 1 6 Minute walk test [ Time Frame: 6 months after intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety Symptom scores [ Time Frame: 6 months after intervention ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	30
Study Start Date:	January 2008
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Intervention Details:

Endobronchial valve system to redirect the airflow within the bronchial system

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

Eligibility

Ages Eligible for Study:	40 Years to 80 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00613860

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

University of Heidelberg

Humboldt-Universität zu Berlin

Investigators

Principal Investigator:

Felix JF Herth, MD, PhD

Thoraxklinik, University of Heidelberg

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
Study First Received:	January 31, 2008
Last Updated:	April 26, 2011
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Heidelberg:

Endoscopic lung volume reduction, heterogeneous emphysema, interventional bronchoscopy

Additional relevant MeSH terms:

Emphysema
Pulmonary Emphysema
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 23, 2013

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