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| ID | Type | Description | Link |
|---|---|---|---|
| 03-C10-001PLV |
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The purpose of this study is to evaluate the safety and efficacy of AeriSeal treatment in patients with advanced emphysema.
The purpose of this study is to evaluate the safety and efficacy of AeriSeal treatment in patients with advanced homogeneous and heterogeneous emphysema.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AeriSeal System | Device | AeriSeal System for Lung Volume Reduction |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in respiratory volume/total lung capacity (RV/TLC) ratio | 12 Weeks following final treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in RV/TLC ratio | 24 and 48 weeks following treatment | |
| Change from baseline in forced expiratory volume in 1 second (FEV1) (post bronchodilator) | 12, 24, 48 weeks following treatment |
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Inclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Otto Wagner Spital Wien Interne Lungenabteilung | Vienna | Austria | ||||
| Service de Pneumologie, Hôpital Pasteur, Centre Hospitalier Universitaire de Nice |
| 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 |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D004646 | Emphysema |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D011656 | Pulmonary Emphysema |
| D008171 | Lung Diseases |
| D053120 | Respiratory Aspiration |
| D010335 | Pathologic Processes |
| D012140 | Respiratory Tract Diseases |
| ID | Term |
|---|---|
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008173 | Lung Diseases, Obstructive |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
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| ID | Term |
|---|---|
| D011013 | Pneumonectomy |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
| D013510 | Pulmonary Surgical Procedures |
| D019616 | Thoracic Surgical Procedures |
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| Change from baseline in MRC dyspnea score | 12, 24, 48 weeks following treatment |
| Change from baseline in 6 minute walk test (MWT) | 12, 24, 48 weeks following treatment |
| Change from baseline in disease-specific health related quality of life assessment (SGRQ) | 12, 24, 48 weeks following treatment |
| Nice |
| France |
| Chefarzt Klinik für Pneumologie | Bad Berka | Germany |
| Thoraxklinik Heidelberg | Heidelberg | Germany |
| Lungenklinik Hemer | Hemer | Germany |
| Medizinische Klinik und Poliklinik Klinikum Großhadern | München | Germany |
| Soroka Medical Center | Beersheba | Israel |
| Rabin Medical Center, Beilinson Hospital | Petah Tikva | Israel |
| D012120 | Respiration Disorders |