Phase 2 Study of the 20 mL Biologic Lung Volume Reduction (BLVR) System in Patients With Homogeneous or Upper Lobe Predominant Emphysema
Sponsor study identifier
interventional
33
1 country
8
Study Start
February 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2009
Actual (reported)Study Completion
December 2009
Actual (reported)The purpose of the study is to evaluate the efficacy and safety of the 20 mL BLVR System in patients with homogeneous emphysema. Patients with upper lobe predominant emphysema initially screened for earlier Phase 2 studies but not enrolled before study enrollment closed are also eligible for participation.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2009
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2008
Date type not reportedThis date has not been verified as actual or estimated.
February 27, 2008
Actual (reported)March 6, 2008
Actual (reported)December 2009
Actual (reported)December 2009
Actual (reported)reduction in gas trapping
12 weeks post treatment
improvement in exercise capacity
12 weeks post treatment
improvement in expiratory flow
12 weeks post treatment
improvement in vital capacity
12 weeks post treatment
improvement in dyspnea sysmptoms
12 weeks post treatment
improvemnet in respiratory quality of life
12 weeks post treatment
all patients are treated with the experimental therapy
20 mL Hydrogel
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University of Alabama
Birmingham, Alabama, 35249, United States
Pulmonary Associates
Phoenix, Arizona, 85006, United States
University of Iowa Hospitals & Clinics
Iowa City, Iowa, 52242, United States
Veritas Clinical Specialties
Topeka, Kansas, 66606, United States
St Josephs Medical Center
Towson, Maryland, 21204, United States
Akron Medical Center
Akron, Ohio, 44302, United States
Cleveland Clinic Foundation, Pulmonary Allergy & Critical Care Medicine
Cleveland, Ohio, 44195, United States
Ingenito EP, Berger RL, Henderson AC, Reilly JJ, Tsai L, Hoffman A. Bronchoscopic lung volume reduction using tissue engineering principles. Am J Respir Crit Care Med. 2003 Mar 1;167(5):771-8. doi: 10.1164/rccm.200208-842OC. Epub 2002 Oct 11.
Reilly J, Washko G, Pinto-Plata V, Velez E, Kenney L, Berger R, Celli B. Biological lung volume reduction: a new bronchoscopic therapy for advanced emphysema. Chest. 2007 Apr;131(4):1108-13. doi: 10.1378/chest.06-1754.
Mark Gotfried, MD
Pulmonary Associates, Phoenix, AZ
Mark Dransfield, MD
University of Alabama, Birmingham, AL
Gerard Criner, MD
Temple University Lung Center, Philadelphia, PA
William Leeds, DO
Veritas Clinical Specialties, Topeka, KS
33 participants (actual enrollment reported by the registry).
First Submitted
February 27, 2008
First Posted
March 6, 2008
Study Start
February 2008
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Temple University Lung Center
Philadelphia, Pennsylvania, 19140, United States
Mark Krasna, MD
St Josephs Medical Center, Towson, MD
Thomas Gildea, MD
Cleveland Clinic, Cleveland, OH
Sanjiv Tewari, MD
Akron Medical Center, Akron, OH
Geoffrey McLennan, MD
University of Iowa Hospitals & Clinics, Iowa City, IA
Primary Completion
December 2009
Actual (reported)Study Completion
December 2009
Actual (reported)Last Updated
October 24, 2011
Record last verified: 2011-10
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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