Ignite Creation Date:
2024-05-05 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00515164
Status:
COMPLETED
Last Update Posted:
2011-10-24
First Post:
2007-08-09
Brief Title:
US Biologic Lung Volume Reduction BLVR Phase 2 Emphysema Study
Sponsor:
Aeris Therapeutics
Organization:
Aeris Therapeutics
Study Overview
Official Title:
Phase 2 Study of the 20 mL Biologic Lung Volume Reduction System BLVR in Patients With Advanced Upper Lobe Predominant Emphysema
Status:
COMPLETED
Status Verified Date:
2011-10
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 it to evaluate the efficacy and safety of the 20 mL BLVR System in patients with advanced upper lobe predominant emphysema
Detailed Description:
Background
Patients with emphysema currently have limited treatment choices Many patients are treated with steroids and inhaled medications which often provide little or no benefit In recent years lung volume reduction surgery has become an accepted therapy for advanced emphysema Lung volume reduction surgery involves the removal of diseased portions of the lung in order to enable the remaining healthier portions of the lung to function better This procedure although effective for many patients is complicated and is accompanied by substantial morbidity and mortality risk
Aeris Therapeutics has developed the Biologic Lung Volume Reduction BLVR System which is intended to achieve lung volume reduction without surgery and its attendant risks Patients are treated using a bronchoscope to direct treatment to the most damaged areas of the lung The treatment delivers a precisely proportioned proprietary mixture of drugs and biologics which when combined at the treatment site form a biodegradable hydrogel The hydrogel acts to reduce lung volume by permanently collapsing and sealing the diseased areas of the lung This provides room within the chest to allow the remaining healthier portions of the lung to function better
Aeris BLVR development program has been granted Fast Track designation by the US FDA and is the subject of ongoing clinical trials designed to investigate the safety and efficacy of the BLVR System as a treatment for patients with advanced heterogeneous emphysema Fast Track designation is reserved for drug and biologic development programs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs
Patients with emphysema currently have limited treatment choices Many patients are treated with steroids and inhaled medications which often provide little or no benefit In recent years lung volume reduction surgery has become an accepted therapy for advanced emphysema Lung volume reduction surgery involves the removal of diseased portions of the lung in order to enable the remaining healthier portions of the lung to function better This procedure although effective for many patients is complicated and is accompanied by substantial morbidity and mortality risk
Aeris Therapeutics has developed the Biologic Lung Volume Reduction BLVR System which is intended to achieve lung volume reduction without surgery and its attendant risks Patients are treated using a bronchoscope to direct treatment to the most damaged areas of the lung The treatment delivers a precisely proportioned proprietary mixture of drugs and biologics which when combined at the treatment site form a biodegradable hydrogel The hydrogel acts to reduce lung volume by permanently collapsing and sealing the diseased areas of the lung This provides room within the chest to allow the remaining healthier portions of the lung to function better
Aeris BLVR development program has been granted Fast Track designation by the US FDA and is the subject of ongoing clinical trials designed to investigate the safety and efficacy of the BLVR System as a treatment for patients with advanced heterogeneous emphysema Fast Track designation is reserved for drug and biologic development programs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs
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