Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00085852
Status:
COMPLETED
Last Update Posted:
2008-03-06
First Post:
2004-06-15
Brief Title:
US 10 mL Bronchoscopic Lung Volume Reduction BLVR Phase 1 Emphysema Study - Initial Formulation
Sponsor:
Aeris Therapeutics
Organization:
Aeris Therapeutics
Study Overview
Official Title:
Phase 1 Study of the Aeris Bronchoscopic Lung Volume Reduction BLVR System in Patients With Advanced Heterogeneous 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 determine whether the Aeris Bronchoscopic Lung Volume Reduction BLVR System is safe in patients with advanced emphysema
Detailed Description:
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
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
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IRB Protocol 2003-P-002171 | None | None | None |