Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT01682018
Status:
UNKNOWN
Last Update Posted:
2012-09-10
First Post:
2012-09-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Value of Bronchoscopic Lung Volume Reduction by Endobronchial Valves in Patients With Single Lung Transplantation and Overinflation of the Native Lung
Sponsor:
Rabin Medical Center
Organization:
Study Overview
Official Title:
Clinical Trial to Evaluate the Value of Bronchoscopic Lung Volume Reduction by Endobronchial Valves in Patients With Single Lung Transplantation and Overinflation of the Native Lung
Status:
UNKNOWN
Status Verified Date:
2012-07
Last Known Status:
NOT_YET_RECRUITING
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 the study is to investigate if bronchoscopic lung volume reduction by valves (Zephyr) would reduce native lung overinflation in patients that underwent single lung transplantation due to emphysema, and improve their well being and pulmonary function tests.
Detailed Description:
Emphysema is a progressive pulmonary disease characterized by abnormal and permanent enlargement of air spaces distal to terminal bronchioles accompanied by the destruction of pulmonary parenchyma. Treatment includes inhaled bronchodilator therapy, rehabilitation and/or oxygen treatment. In addition to the above, patients with severe emphysema may benefit from surgical lung volume reduction and/or lung transplantation. The rationale for lung volume reduction surgery is that reducing lung size would restore elastic recoil of the lung and improve chest wall and diaphragm mechanics. It has previously been shown that particularly patients with heterogeneous emphysema seem to benefit most from surgical lung volume reduction.
Bronchoscopic lung volume reduction (BLVR) has recently been introduced as a less invasive potential alternative to surgical lung volume reduction. BLVR attempts to achieve the effects of surgery, by placing bronchial prostheses using a fibreoptic bronchoscope to selectively occlude the airways supplying the most affected hyperinflated regions of the emphysematous lung, while permitting exhaled gas to escape. This attempts to achieve segmental or lobar volume reduction, simulating the effects of surgical LVR.
The purpose of the study is to investigate if bronchoscopic lung volume reduction by valves (Zephyr) would reduce native lung overinflation in patients that underwent single lung transplantation due to emphysema, and improve their well being and pulmonary function tests
Bronchoscopic lung volume reduction (BLVR) has recently been introduced as a less invasive potential alternative to surgical lung volume reduction. BLVR attempts to achieve the effects of surgery, by placing bronchial prostheses using a fibreoptic bronchoscope to selectively occlude the airways supplying the most affected hyperinflated regions of the emphysematous lung, while permitting exhaled gas to escape. This attempts to achieve segmental or lobar volume reduction, simulating the effects of surgical LVR.
The purpose of the study is to investigate if bronchoscopic lung volume reduction by valves (Zephyr) would reduce native lung overinflation in patients that underwent single lung transplantation due to emphysema, and improve their well being and pulmonary function tests
Study Oversight
Has Oversight DMC:
False
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?: