A Secondary Study Evaluating Aqueduct's Smart External Drain (SED)

Study Overview
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Brief Summary
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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. Evaluate the number of subjects requiring to be switched to a standard of care EVD Evaluate subject transport while on the SED Evaluate SED system control from initiation of SED through discharge of external drain system

Detailed Description
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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.

Official Title
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A Secondary Study Evaluating Performance and Safety of Aqueduct's Smart External Drain (SED2)

Conditions
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Hydrocephalus, Hydrocephalus in Children, Tumor, Brain, Subarachnoid Hemorrhage

Intervention / Treatment
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* Device: Smart External Drain - SED


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject scheduled to have an external drain (includes extra-ventricular and lumbar drains) placed as part of routine management. Age 0-80. Able to obtain consent or legally authorized representative (LAR) consents for subject to be treated on study. Exclusion Criteria: Anticoagulant therapy (does not include DVT or PE prophylaxis). Known bleeding diathesis. Scalp infection. In the opinion of the Investigator the subject is not a good study candidate.

Ages Eligible for Study
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Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Arm Study<br>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. | Device: Smart External Drain - SED<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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. | 
| 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. |