Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00207337
Status:
COMPLETED
Last Update Posted:
2008-01-23
First Post:
2005-09-12
Brief Title:
Exhale R Stent for Emphysema
Sponsor:
Broncus Technologies
Organization:
Broncus Technologies
Study Overview
Official Title:
A Prospective Feasibility Study to Evaluate the Safety and Performance of the ExhaleR Drug-Eluting Stent System in Patients With Emphysema
Status:
COMPLETED
Status Verified Date:
2008-01
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:
Current treatment for emphysema is limited to measures that include inhaled oxygen bronchodilators anti-inflammatory drugs and pulmonary rehabilitation Highly invasive procedures such as lung volume reduction surgery or lung transplantation are also performed Treatment using the Exhale Drug-Eluting Stent DES is a minimally invasive bronchoscopic treatment that has the potential to reduce shortness of breath in emphysema patients This study tests the safety and effects of Exhale DES in the treatment of patients with emphysema
Detailed Description:
Emphysema affects an estimated 60 million people worldwide and is a major cause of morbidity and mortality In its most basic terms emphysema causes the destruction of lung parenchyma resulting in collateral ventilation from one part of the lung to another through the disrupted alveolar walls to the point that gas transport from one part of the lung to another may exceed gas flow through the small airways In other words the gas can move freely about within the lung but it cannot get out which causes over inflation or hyperinflation of the diseased lung When the disease is far advanced patients are afflicted with disabling dyspnea that progressively restricts their activities and eventually causes great suffering The crippling effects of end-stage emphysema including severe dyspnea and marked limitation of activities relate in large measure to the dynamic hyperinflation of the lungs associated with the loss of elasticity gas trapping and collapse of small airways The progressive enlargement of the thorax and flattening of the diaphragm render inspiratory muscles inefficient increase the work of breathing and contribute to a feeling of breathlessness The major medical therapeutic modalities include bronchodilator and anti-inflammatory drugs directed at decreasing airway resistance and antibiotics to combat infection Pulmonary rehabilitation techniques and exercise training have proven of palliative benefit In general the results of medical treatment for advanced airway obstruction frequently result in a persistently anguished patient and frustrated physician A system that could efficiently decompress emphysematous lungs with each breath would result in significant clinical benefit including lessened dyspnea decreased work of breathing and increased exercise tolerance
In addition to medical therapies there are two surgical therapies available to emphysema sufferers Lung transplantation and Lung Volume Reduction Surgery LVRS In the National Emphysema Treatment Trial NETT LVRS was shown to be effective in a sub-set of emphysema patients but it had the drawback of increased short-term mortality as compared to the medical control arm This was likely due to the invasiveness of LVRS
Lung transplantation is a widely accepted surgical treatment for emphysema however it is an unrealistic option for most patients The selection criteria are very stringent for acceptance to receive a donor lungs Lung transplantation carries a high long-term morbidity and mortality and is severely limited by the shortage of available donor lungs
We seek to take advantage of collateral ventilation seen in advanced emphysema by creating passageways from the lung parenchyma to large airways through which air can escape the lungs during exhalation The Exhale therapeutic intervention should be applicable to the majority of emphysema patients who suffer from hyperinflation of their lungs It would be desirable to have a therapeutic option that is both less invasive and more readily available to emphysema sufferers We have been working on such a therapy and have begun to investigate it in the clinic
In addition to medical therapies there are two surgical therapies available to emphysema sufferers Lung transplantation and Lung Volume Reduction Surgery LVRS In the National Emphysema Treatment Trial NETT LVRS was shown to be effective in a sub-set of emphysema patients but it had the drawback of increased short-term mortality as compared to the medical control arm This was likely due to the invasiveness of LVRS
Lung transplantation is a widely accepted surgical treatment for emphysema however it is an unrealistic option for most patients The selection criteria are very stringent for acceptance to receive a donor lungs Lung transplantation carries a high long-term morbidity and mortality and is severely limited by the shortage of available donor lungs
We seek to take advantage of collateral ventilation seen in advanced emphysema by creating passageways from the lung parenchyma to large airways through which air can escape the lungs during exhalation The Exhale therapeutic intervention should be applicable to the majority of emphysema patients who suffer from hyperinflation of their lungs It would be desirable to have a therapeutic option that is both less invasive and more readily available to emphysema sufferers We have been working on such a therapy and have begun to investigate it in the clinic
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