A Study Evaluate Aqueduct's Smart External Drain

Study Overview
=================
Brief Summary
-----------------
To evaluate the performance characteristics of the Smart External Drain (SED) compared with standard EVD drains in the hospital setting, specifically: Number, type and duration of staff interactions. Regulating and controlling ICP and CSF drainage. Maintaining system control with patient movement.

Detailed Description
-----------------
In this two day clinical trial, subjects will be observed on Day 1 of study during their routine treatment and using their already existing EVD. On Day 2 of study; subjects will be switched to the Smart External Drain for monitoring and management of ICP and CSF

Official Title
-----------------
A Study to Evaluate the Performance and Safety of Aqueduct's Smart External Device (SED) Compared to Standard EVD Drains

Conditions
-----------------
Hydrocephalus, Hydrocephalus in Children, Tumor, Brain

Intervention / Treatment
-----------------
* Device: Smart External Drain - SED


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stable Neuro - examination on standard EVD assessed as Not Clinically Significant (NCS) by PI or delegated Sub-I prior to study treatment. GCS > 13 (minimum of E3V5M5) prior to study treatment. Subject must be scheduled to have an EVD placed as part of routine management and for a length of at least 48 hours. (e.g. in the setting of a tumor removal or treatment of hydrocephalus) Age 5-80. Stable Vital Signs - Blood pressure (Systolic and Diastolic), Heart Rate, Respiratory Rate and weight assessed as not clinically significant (NCS) and afebrile as per PI/Sub-assessment. (Stable Vital signs will be re-assessed again prior to treatment with the SED on Day 2) Able to perform and follow simple commands (ex: sit up in bed, lay down in bed) Pre-Study CT/MRI Imaging stable per PI Sub-I Assessment post ventriculostomy. Able to stand Able to obtain consent Exclusion Criteria: Refractory ICP or needing active ICP management Unable to tolerate brief clamping of EVD (<5min) Unable to follow simple commands Unconscious Anticoagulant Therapy Known bleeding diathesis Scalp Infection In the opinion of the Investigator the subject is not a good study candidate

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: In this study the subject will act as their own control and will be treated on day one with the standard of care EVD and then on Day 2 treated with the SED.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single Arm study<br>Single Arm study In this study, the subject will act as their own control. On Day 1 of the two day study, the subject will be observed while treated on their standard EVD. On Day 2, the subject will be treated with the Smart External Drain (SED). | Device: Smart External Drain - SED<br>* Subject will be treated on Day 2 with the SED. ICP and CSF volumes will be recorded at prespecified intervals while subject is stationary and while subject is engaged in protocol-driven directed movements.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Staff interactions | Average number of staff interactions per patient with standard EVD compared to intervention, the Smart External Drain (SED) | Two Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Staff Time | Total minutes spent by staff interacting with standard EVD compared to SED | Two Days | 
| Safety | Number of Participants with Adverse Events That Are Related to Treatment | Two Days |