Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE3
INTERVENTIONAL
2008-01-31
2012-04-30
Brief Summary
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Detailed Description
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Follow-up period 6 months Primary end points: FEV 1, 6-Minute walk test Secondary endpoints. Safety, Symptom scores Number of patients planned 30
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Zephyr endobronchial valve
Endobronchial valve system to redirect the airflow within the bronchial system
Eligibility Criteria
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Inclusion Criteria
* FEV1 \< 45%
* RV \> 150%
* TLC \> 100%
* TLCO \< 40%
Exclusion Criteria
* Pregnancy
* PCO2 \> 50 mmHg
40 Years
80 Years
ALL
No
Sponsors
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Humboldt-Universität zu Berlin
OTHER
Heidelberg University
OTHER
Responsible Party
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Felix JF Herth
CEO
Principal Investigators
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Felix JF Herth, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Thoraxklinik University of Heidelberg
Locations
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Charite, University of Berlin
Berlin, , Germany
Thoraxklinik, University of Heidelberg
Heidelberg, , Germany
Medical Center Nürnberg
Nuremberg, , Germany
Countries
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References
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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. doi: 10.1186/1471-2466-7-10.
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. doi: 10.1378/chest.130.1.190.
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. doi: 10.1016/j.athoracsur.2004.07.048.
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. doi: 10.1016/j.jtcvs.2003.10.005.
Shah PL, Gompelmann D, Valipour A, McNulty WH, Eberhardt R, Grah C, Egan J, Ficker JH, Wagner M, Witt C, Liebers U, Hopkins P, Gesierich W, Phillips M, Stanzel F, Petermann C, Strange C, Snell G, Herth FJF. Thermal vapour ablation to reduce segmental volume in patients with severe emphysema: STEP-UP 12 month results. Lancet Respir Med. 2016 Sep;4(9):e44-e45. doi: 10.1016/S2213-2600(16)30199-0. Epub 2016 Jul 20. No abstract available.
Other Identifiers
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02/08
Identifier Type: -
Identifier Source: org_study_id
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