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

Primary Purpose

Hydrocephalus, Hydrocephalus in Children, Tumor, Brain

Status
Terminated
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

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

Inclusion Criteria:

  1. Subject scheduled to have an external drain (includes extra-ventricular and lumbar drains) placed as part of routine management.
  2. Age 0-80.
  3. Able to obtain consent or legally authorized representative (LAR) consents for subject to be treated on study.

Exclusion Criteria:

  1. Anticoagulant therapy (does not include DVT or PE prophylaxis).
  2. Known bleeding diathesis.
  3. Scalp infection.
  4. In the opinion of the Investigator the subject is not a good study candidate.

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single Arm Study

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
February 28, 2018
Last Updated
July 9, 2019
Sponsor
Aqueduct Critical Care
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1. Study Identification

Unique Protocol Identification Number
NCT03471702
Brief Title
A Secondary Study Evaluating Aqueduct's Smart External Drain (SED)
Official Title
A Secondary Study Evaluating Performance and Safety of Aqueduct's Smart External Drain (SED2)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Terminated
Why Stopped
Device Review performed by Sponsor
Study Start Date
February 28, 2018 (Actual)
Primary Completion Date
November 1, 2018 (Actual)
Study Completion Date
November 1, 2018 (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
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
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.

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, Subarachnoid Hemorrhage

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single Arm Study
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Smart External Drain - SED
Intervention Description
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.
Primary Outcome Measure Information:
Title
The number of subjects which require switching to a standard of care external drain.
Description
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.
Time Frame
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 Measure Information:
Title
Subject transport while on the SED system.
Description
Evaluating subject transport while on the SED system, specifically, the number of minutes a subject will require clamping of the drain while being transported.
Time Frame
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.
Title
Evaluating SED system control throughout duration of study.
Description
SED system control will be evaluated from initiation of ICP management through discharge of the subject's external drain.
Time Frame
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.

10. Eligibility

Sex
All
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
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
Texas Children's Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
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

Learn more about this trial

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

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