AeriSeal® System for Lung Volume Reduction in Patients With Advanced Emphysema
|ClinicalTrials.gov Identifier: NCT01181466|
Recruitment Status : Completed
First Posted : August 13, 2010
Last Update Posted : October 21, 2011
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Emphysema COPD Lung Diseases||Device: AeriSeal System||Phase 2 Phase 3|
Emphysema is a progressive, debilitating disease characterized by destruction of lung tissue as a result of inflammation caused by exposure to noxious inhaled agents for extended periods. The most common cause of this condition is cigarette smoking, although genetic, occupational, and environmental causes account for up to 10% of cases. Despite aggressive public health initiatives aimed at discouraging the use of cigarettes, smoking-related lung diseases remain a significant cause of disability and death worldwide. Due to the number of current and new smokers, emphysema is expected to remain a leading cause of morbidity and mortality for years to come.
The AeriSeal System is a novel device system being developed for the treatment of advanced emphysema. The AeriSeal System is administered bronchoscopically, and designed to provide the physiological benefits of lung volume reduction without the risks and cost of major surgery.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Study of the AeriSeal® System Administered at 3 to 4 Sites During a Single Treatment Session for Lung Volume Reduction in Patients With Advanced Emphysema|
|Study Start Date :||August 2010|
|Actual Primary Completion Date :||May 2011|
|Actual Study Completion Date :||May 2011|
- Device: AeriSeal System
The AeriSeal System will be Administered at 3 to 4 Pulmonary Subsegments During a Single Treatment session.
- Change in Percent Volume of Lung [ Time Frame: 12 weeks following treatment ]Computed Tomography (CT) evidence of lobar volume reduction at site(s) of AeriSeal Foam Sealant administration at 12 weeks post treatment, assessed quantitatively by digital integration of CT dicom images collected using a standardized image acquisition and reconstruction algorithm.
- Change in the ratio of Residual Volume (RV) to Total Lung Capacity (TLC) [ Time Frame: 12 weeks following treatment ]Change from baseline at 12 weeks in RV/TLC
- Change in Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: 12 weeks following treatment ]Change from baseline at 12 weeks in FEV1
- Change in Forced Vital Capacity (FVC) [ Time Frame: 12 weeks following treatment ]Change from baseline at 12 weeks in FVC
- Change in distance walked in six minutes [ Time Frame: 12 weeks following treatment ]Change from baseline at 12 weeks in 6 Minute Walk Test (6MWT)
- Change in Medical Research Council Dyspnea (MRCD) score [ Time Frame: 12 weeks following treatment ]Change from baseline at 12 weeks in MRCD score
- Change in St. George's Respiratory Questionnaire (SGRQ) domain score [ Time Frame: 12 weeks following treatment ]Change from baseline at 12 weeks in SGRQ total domain score
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01181466
|The Soroka Medical Center|
|Beer Sheva, Israel|
|The Rabin Medical Center|
|Petah Tikva, Israel|