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

Not Applicable

Terminated

• Conditions: Hydrocephalus in Children; Subarachnoid Hemorrhage; Hydrocephalus; Tumor, Brain
• Interventions: Device: Smart External Drain - SED

• Registration Number: NCT03471702
• Lead Sponsor: Aqueduct Critical Care

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.

Study Timeline

• Study Start: 2018-02-28
• Study First Submitted: 2018-02-28
• Status Verified: 2018-03
• Study First Submitted QC: 2018-03-19
• Study First Posted: 2018-03-21
• Primary Completion: 2018-11-01
• Study Completion: 2018-11-01
• Last Update Submitted: 2019-07-09
• Last Update Posted: 2019-07-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm Study	Smart External Drain - SED	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.

Primary Outcome Measures

Name	Time	Method
The number of subjects which require switching to a standard of care 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.	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

Name	Time	Method
Subject transport while on the SED system.	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 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.	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.	SED system control will be evaluated from initiation of ICP management through discharge of the subject's external drain.

Trial Locations

Locations (3)

Texas Children's Hospital; 🇺🇸 Houston, Texas, United States

Seattle Children's Hospital; 🇺🇸 Seattle, Washington, United States

University of Washington School of Medicine, Harborview Medical Center; 🇺🇸 Seattle, Washington, United States