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A Study Evaluate Aqueduct's Smart External Drain (SED)

Primary Purpose

Hydrocephalus, Hydrocephalus in Children, Tumor, Brain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Smart External Drain - SED
Sponsored by
Aqueduct Critical Care
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hydrocephalus

Eligibility Criteria

5 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Stable Neuro - examination on standard EVD assessed as Not Clinically Significant (NCS) by PI or delegated Sub-I prior to study treatment.
  2. GCS > 13 (minimum of E3V5M5) prior to study treatment.
  3. 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)
  4. Age 5-80.
  5. 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)
  6. Able to perform and follow simple commands (ex: sit up in bed, lay down in bed)
  7. Pre-Study CT/MRI Imaging stable per PI Sub-I Assessment post ventriculostomy.
  8. Able to stand
  9. Able to obtain consent

Exclusion Criteria:

  1. Refractory ICP or needing active ICP management
  2. Unable to tolerate brief clamping of EVD (<5min)
  3. Unable to follow simple commands
  4. Unconscious
  5. Anticoagulant Therapy
  6. Known bleeding diathesis
  7. Scalp Infection
  8. In the opinion of the Investigator the subject is not a good study candidate

Sites / Locations

  • Seattle Children's Hospital
  • University of Washington School of Medicine / Harborview Medical Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Single Arm study

Arm Description

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).

Outcomes

Primary Outcome Measures

Staff interactions
Average number of staff interactions per patient with standard EVD compared to intervention, the Smart External Drain (SED)

Secondary Outcome Measures

Staff Time
Total minutes spent by staff interacting with standard EVD compared to SED
Safety
Number of Participants with Adverse Events That Are Related to Treatment

Full Information

First Posted
March 20, 2017
Last Updated
January 29, 2019
Sponsor
Aqueduct Critical Care
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1. Study Identification

Unique Protocol Identification Number
NCT03113799
Brief Title
A Study Evaluate Aqueduct's Smart External Drain
Acronym
SED
Official Title
A Study to Evaluate the Performance and Safety of Aqueduct's Smart External Device (SED) Compared to Standard EVD Drains
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
April 12, 2017 (Actual)
Primary Completion Date
August 15, 2018 (Actual)
Study Completion Date
January 29, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aqueduct Critical Care

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hydrocephalus, Hydrocephalus in Children, Tumor, Brain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single Arm study
Arm Type
Other
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
Smart External Drain - SED
Intervention Description
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.
Primary Outcome Measure Information:
Title
Staff interactions
Description
Average number of staff interactions per patient with standard EVD compared to intervention, the Smart External Drain (SED)
Time Frame
Two Days
Secondary Outcome Measure Information:
Title
Staff Time
Description
Total minutes spent by staff interacting with standard EVD compared to SED
Time Frame
Two Days
Title
Safety
Description
Number of Participants with Adverse Events That Are Related to Treatment
Time Frame
Two Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sam Browd, MD, PhD
Organizational Affiliation
Aqueduct Critical Care, Inc
Official's Role
Study Director
Facility Information:
Facility Name
Seattle Children's Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
University of Washington School of Medicine / Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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A Study Evaluate Aqueduct's Smart External Drain

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