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The purpose of this study is to assess the procedural and post-procedural safety and efficacy of AeriSeal therapy at up to 4 subsegments during a single treatment session in patients with GOLD Stage III/IV homogeneous or heterogeneous emphysema.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AeriSeal System | Device | The AeriSeal System will be Administered at 3 to 4 Pulmonary Subsegments During a Single Treatment session. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Percent Volume of Lung | 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. | 12 weeks following treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the ratio of Residual Volume (RV) to Total Lung Capacity (TLC) | Change from baseline at 12 weeks in RV/TLC | 12 weeks following treatment |
| Change in Forced Expiratory Volume in 1 Second (FEV1) |
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Inclusion Criteria:
Exclusion Criteria:
-
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Soroka Medical Center | Beersheba | Israel | ||||
| The Rabin Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22374920 | Derived | Magnussen H, Kramer MR, Kirsten AM, Marquette C, Valipour A, Stanzel F, Bonnet R, Behr J, Fruchter O, Refaely Y, Eberhardt R, Herth FJ. Effect of fissure integrity on lung volume reduction using a polymer sealant in advanced emphysema. Thorax. 2012 Apr;67(4):302-8. doi: 10.1136/thoraxjnl-2011-201038. Epub 2012 Feb 28. |
| Label | URL |
|---|---|
| Aeris Therapeutics | View source |
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| ID | Term |
|---|---|
| D011656 | Pulmonary Emphysema |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D008171 | Lung Diseases |
| D053120 | Respiratory Aspiration |
| D004646 | Emphysema |
| D010335 | Pathologic Processes |
| D012140 | Respiratory Tract Diseases |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Change from baseline at 12 weeks in FEV1
| 12 weeks following treatment |
| Change in Forced Vital Capacity (FVC) | Change from baseline at 12 weeks in FVC | 12 weeks following treatment |
| Change in distance walked in six minutes | Change from baseline at 12 weeks in 6 Minute Walk Test (6MWT) | 12 weeks following treatment |
| Change in Medical Research Council Dyspnea (MRCD) score | Change from baseline at 12 weeks in MRCD score | 12 weeks following treatment |
| Change in St. George's Respiratory Questionnaire (SGRQ) domain score | Change from baseline at 12 weeks in SGRQ total domain score | 12 weeks following treatment |
| Petah Tikva |
| Israel |
| D012120 | Respiration Disorders |