Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00347659
Status:
COMPLETED
Last Update Posted:
2008-03-06
First Post:
2006-06-30
Brief Title:
US 10 mL Biologic Lung Volume Reduction BLVR Phase 1 Emphysema Study
Sponsor:
Aeris Therapeutics
Organization:
Aeris Therapeutics
Study Overview
Official Title:
Phase 1 Study of the Biologic Lung Volume Reduction BLVR System in Patients With Advanced Upper Lobe Predominant Emphysema
Status:
COMPLETED
Status Verified Date:
2008-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the safety of the Biologic Lung Volume Reduction System BLVR for patients with advanced emphysema
Detailed Description:
Emphysema is a progressive debilitating disease that affects nearly 3 million people in the United States or roughly one percent of the US population The disease is characterized by destruction of lung tissue as a result of inflammation caused by exposure to noxious inhaled agents for extended periods The most common cause of this condition is cigarette smoking although genetic and occupational causes account for up to 10 of cases Despite aggressive public health initiatives aimed at discouraging the use of cigarettes smoking-related lung diseases remain a significant cause of disability and death in the United States Currently there are 46 million smokers in the US Due to the number of current and new smokers emphysema is expected to remain a leading cause of morbidity and mortality in the United States for years to come
Aeris has developed a novel bronchoscopic system for achieving the benefits of lung volume reduction without surgery The Biologic Lung Volume Reduction BLVR System a new investigational therapy for emphysema is intended to reduce lung volume over a period of weeks by collapsing and promoting the remodeling of diseased areas of the lung The resulting reduction in lung volume is intended to restore a more normal physiological relationship between lung and chest wall improve breathing and exercise capacity and alleviate symptoms of chronic dyspnea This study will evaluate the safety of the BLVR System in patients with advanced emphysema
Aeris has developed a novel bronchoscopic system for achieving the benefits of lung volume reduction without surgery The Biologic Lung Volume Reduction BLVR System a new investigational therapy for emphysema is intended to reduce lung volume over a period of weeks by collapsing and promoting the remodeling of diseased areas of the lung The resulting reduction in lung volume is intended to restore a more normal physiological relationship between lung and chest wall improve breathing and exercise capacity and alleviate symptoms of chronic dyspnea This study will evaluate the safety of the BLVR System in patients with advanced emphysema
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None