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Sponsored by: |
Aeris Therapeutics |
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Information provided by: | Aeris Therapeutics |
ClinicalTrials.gov Identifier: | NCT00085852 |
The purpose of this study is to determine whether the Aeris Bronchoscopic Lung Volume Reduction (BLVR) System is safe in patients with advanced emphysema.
Condition | Intervention | Phase |
---|---|---|
Pulmonary Emphysema |
Biological: BLVR |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | Phase 1 Study of the Aeris Bronchoscopic Lung Volume Reduction (BLVR) System in Patients With Advanced Heterogeneous Emphysema |
Enrollment: | 6 |
Study Start Date: | April 2005 |
Study Completion Date: | June 2007 |
Primary Completion Date: | October 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Single: Experimental
Treatment with BLVR
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Biological: BLVR
10 mL Hydrogel
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Patients with emphysema currently have limited treatment choices. Many patients are treated with steroids and inhaled medications, which often provide little or no benefit. Recently, lung volume reduction surgery has become an accepted therapy for emphysema. Lung volume reduction surgery involves the removal of a diseased portion of the lung, which enables the remaining, healthier portions of the lung to function better. This procedure, although effective, is complicated and risky.
Aeris Therapeutics has developed the Aeris Bronchoscopic Lung Volume Reduction System for treatment of patients with advanced emphysema. The Aeris BLVR System is designed to reduce lung volume without surgery. Patients are treated under anesthesia using a bronchoscope to direct treatment to the most damaged areas of the lung. The treatment is expected to reduce lung volume by shrinking the diseased areas of the lung. The purpose of the current study is to find out whether the Aeris BLVR System is safe in patients with advanced emphysema. The risks associated with the treatment are expected to be similar to those associated with general anesthesia and bronchoscopy.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
United States, Massachusetts | |
Brigham and Women's Hospital | |
Boston, Massachusetts, United States, 02115 | |
Caritas St Elizabeth's Medical Center | |
Boston, Massachusetts, United States, 02135 |
Principal Investigator: | John J. Reilly, MD | Brigham and Women's Hospital |
Responsible Party: | Aeris Therapeutics Inc ( Edward P Ingenito, MD, PhD, Medical Director & CSO ) |
Study ID Numbers: | C04-001, IRB Protocol # 2003-P-002171 |
Study First Received: | June 15, 2004 |
Last Updated: | February 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00085852 |
Health Authority: | United States: Food and Drug Administration |
emphysema chronic obstructive pulmonary disease lung volume reduction |
bronchoscopic bronchoscopy bronchoscope |
Pulmonary Emphysema Emphysema Lung Diseases, Obstructive |
Respiratory Tract Diseases Lung Diseases Pulmonary Disease, Chronic Obstructive |
Pathologic Processes |