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

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

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

Study Overview

• Status: Terminated
• Conditions: Subarachnoid Hemorrhage; Hydrocephalus; Hydrocephalus in Children; Tumor, Brain
• Intervention / Treatment: Device: Smart External Drain - SED

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Texas Children's Hospital
  • Washington
    • Seattle, Washington, United States, 98105
      • Seattle Children's Hospital
    • Seattle, Washington, United States, 98195
      • University of Washington School of Medicine, Harborview Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 80 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Single Arm Study; 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; 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.

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Aqueduct Critical Care
• Investigators: Study Director: Sam Browd, MD, PhD, Aqueduct Critical Care, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 28, 2018
• Primary Completion (ACTUAL): November 1, 2018
• Study Completion (ACTUAL): November 1, 2018

Study Registration Dates

• First Submitted: February 28, 2018
• First Submitted That Met QC Criteria: March 19, 2018
• First Posted (ACTUAL): March 21, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 11, 2019
• Last Update Submitted That Met QC Criteria: July 9, 2019
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Central Nervous System Neoplasms; Nervous System Neoplasms; Intracranial Hemorrhages; Hemorrhage; Brain Neoplasms; Subarachnoid Hemorrhage; Hydrocephalus
• Other Study ID Numbers: ASSESSED SED2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• 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