Ignite Creation Date:
2024-05-06 @ 2:40 AM
Last Modification Date:
2024-10-26 @ 11:22 AM
Study NCT ID:
NCT02107209
Status:
COMPLETED
Last Update Posted:
2015-11-11
First Post:
2014-04-02
Brief Title:
Low Cost Biological Lung Volume Reduction Therapy for Advanced Emphysema
Sponsor:
Mansoura University
Organization:
Mansoura University
Study Overview
Official Title:
Evaluation of Bronchoscopic Biological Lung Volume Reduction Therapy in Pulmonary Emphysema Patients
Status:
COMPLETED
Status Verified Date:
2015-11
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:
BLVR
Brief Summary:
The clinical utility of bronchoscopic methods for achieving lung volume reduction has been evaluated in patients with advanced emphysema because these procedures are uniformly safer than surgical volume reduction These include one-way valves or bronchial occlusive devices to collapse emphysematous regions of lung and bronchial fenestration with bypass stents to improve expiratory flow wire coils implants that compress the airway and thermal vapor ablation that causes an acute injury with subsequent fibrosis and reductions in volume
Detailed Description:
Biologic lung volume reduction BioLVR it is a novel endobronchial approach which uses a Biological agents aiming to reduce lung volume by blocking off the most emphysematous areas with a rapidly polymerizing sealant The mechanism of action involves resorption atelectasis from airway occlusion subsequent airspace inflammation and then remodeling This remodeling will lead to scarring that induces contraction of lung parenchyma and functional volume reduction can be expected within 6-8 weeks Biological lung volume reduction occurs independent of the presence or absence of collateral ventilation
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