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| Name | Class |
|---|---|
| Merit Medical Systems, Inc. | INDUSTRY |
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In this study, the investigators will collect data on patients who are using the Aspira system as part of their clinical care for the management of recurrent pleural effusion. Data will be collected on patient demographics, placement of the pleural catheter, palliation of dyspnea, complication rates, and rates of spontaneous pleurodesis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aspira Catheter & Drainage System |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aspira Catheter | Device |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Relief of dyspnea as measured using the Visual Analog Scale for Dyspnea (VAS-Dyspnea) |
| Through 2 weeks following catheter insertion |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of infection | -Defined as the isolation of any bacteria within a pleural fluid specimen drawn for clinical purposes | 1 year |
| Rate of spontaneous pleurodesis | -Defined as pleural fluid drainage less than 75ml every other day for three consecutive drainage sessions |
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Inclusion Criteria:
Male or female, at least 18 years of age, inclusive
Subject has a symptomatic malignant pleural effusion requiring intervention. For an effusion to be defined as malignant, at least one of the following must be true
Subject is able to provide informed consent
Subject has sufficient pleural fluid to allow safe insertion of an indwelling tunneled pleural catheter as determined by the PI
Subject is able to perform home drainage of the pleural effusion or has sufficient resources (family member, caregiver, home health).
Exclusion Criteria:
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The participants will be seen at Washington University School of Medicine.
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| Name | Affiliation | Role |
|---|---|---|
| Alexander Chen, M.D. | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
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| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
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| ID | Term |
|---|---|
| D016066 | Pleural Effusion, Malignant |
| ID | Term |
|---|---|
| D010997 | Pleural Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D019220 | High-Energy Shock Waves |
| ID | Term |
|---|---|
| D000069453 | Ultrasonic Waves |
| D013016 | Sound |
| D011840 | Radiation, Nonionizing |
| D011827 | Radiation |
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| Ultrasound | Procedure | Standard of care |
|
| 1 year |
| D009369 |
| Neoplasms |
| D010996 | Pleural Effusion |
| D010995 | Pleural Diseases |
| D012140 | Respiratory Tract Diseases |
| D055585 |
| Physical Phenomena |