Advanced Upper Lobe Predominant Emphysema Clinical Trial
Official title:
Phase 3 Study of the Biologic Lung Volume Reduction (BLVR) System in Patients With Advanced Upper Lobe Predominant Emphysema
Verified date | January 2010 |
Source | Aeris Therapeutics |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The purpose of the study is to evaluate the efficacy and safety of the 20 mL BLVR System in treating patients with advanced upper lobe predominant emphysema.
Status | Withdrawn |
Enrollment | 225 |
Est. completion date | December 2009 |
Est. primary completion date | December 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Aeris Therapeutics |
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. Epub 2002 Oct 11. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Improvement in pulmonary function and respiratory symptoms | 6 months | No |