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Device Review performed by Sponsor
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Aqueduct's Smart External Drain (SED) will be compared to the current gold standard for temporary CSF management in a hospital setting.
This clinical trial will evaluate Aqueduct's Smart External Drain (SED) upon implementation of ventriculostomy or lumbar drain placement for temporary CSF external management in a hospital setting. Subjects will remain on study from the time of SED application through discharge of the external drain or switch to standard of care extraventricular drain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm Study | Experimental | All subjects enrolled on study will utilize Aqueduct's Smart External Drain (SED) from the time of external drain implementation until end of study upon discharge of SED or switch to standard of care external drain. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Smart External Drain - SED | Device | Aqueduct's Smart External Drain (SED) is a gravity based system which utilizes a proprietary reference shroud which eliminates the need for manual adjustment of the system in the external management of CSF drainage. |
| Measure | Description | Time Frame |
|---|---|---|
| The number of subjects which require switching to a standard of care external drain. | Evaluating the number of subjects which require switching to a standard of care external drain versus the number of subjects which remain on the SED until study completion or discharge of the external drain. | The study review and data collection period will begin at the time SED is connected to the ventriculostomy catheter until discharge of ventriculostomy catheter; when subject no longer requires an external drain, assessed up to 90 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Subject transport while on the SED system. | Evaluating subject transport while on the SED system, specifically, the number of minutes a subject will require clamping of the drain while being transported. | Subject transport review and data collection will begin when the patient is moved from their primary hospital bed location until they reach a new secondary location or are returned to the primary location. Assessed up to 90 days. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sam Browd, MD, PhD | Aqueduct Critical Care, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Texas Children's Hospital | Houston | Texas | 77030 | United States | ||
| Seattle Children's Hospital |
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| ID | Term |
|---|---|
| D006849 | Hydrocephalus |
| D001932 | Brain Neoplasms |
| D013345 | Subarachnoid Hemorrhage |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D016543 | Central Nervous System Neoplasms |
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| Evaluating SED system control throughout duration of study. | SED system control will be evaluated from initiation of ICP management through discharge of the subject's external drain. | The study review and data collection period will begin at the time SED is connected to the ventriculostomy catheter until discharge of ventriculostomy catheter; when subject no longer requires an external drain, assessed up to 90 days. |
| Seattle |
| Washington |
| 98105 |
| United States |
| University of Washington School of Medicine, Harborview Medical Center | Seattle | Washington | 98195 | United States |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |