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

Subarachnoid Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03471702
• Other study ID #: ASSESSED SED2
• Status: Terminated
• Phase: N/A
• Start date: February 28, 2018
• Est. completion date: November 1, 2018

Study information

• Verified date: March 2018
• Source: Aqueduct Critical Care
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: November 1, 2018
• Est. primary completion date: November 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Neoplasms
• Hemorrhage
• Hydrocephalus
• Hydrocephalus in Children
• Subarachnoid Hemorrhage
• Tumor, Brain

Intervention

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.

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Aqueduct Critical Care

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.