NCT03471702

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Aqueduct Critical Care · Industry
• Sex: All
• Age: 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-02-28
• Primary completion: 2018-11-01
• Completion: 2018-11-01
• First posted: 2018-03-21
• Last updated: 2019-07-11

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study