NCT03113799

A Study Evaluate Aqueduct's Smart External Drain

A Study to Evaluate the Performance and Safety of Aqueduct's Smart External Device (SED) Compared to Standard EVD Drains

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Aqueduct Critical Care · Industry
• Sex: All
• Age: 5 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the performance characteristics of the Smart External Drain (SED) compared with standard EVD drains in the hospital setting, specifically: * Number, type and duration of staff interactions. * Regulating and controlling ICP and CSF drainage. * Maintaining system control with patient movement.

Detailed description

In this two day clinical trial, subjects will be observed on Day 1 of study during their routine treatment and using their already existing EVD. On Day 2 of study; subjects will be switched to the Smart External Drain for monitoring and management of ICP and CSF

Conditions

• Hydrocephalus
• Hydrocephalus in Children
• Tumor, Brain

Interventions

Type	Name	Description
DEVICE	Smart External Drain - SED	Subject will be treated on Day 2 with the SED. ICP and CSF volumes will be recorded at prespecified intervals while subject is stationary and while subject is engaged in protocol-driven directed movements.

Timeline

• Start date: 2017-04-12
• Primary completion: 2018-08-15
• Completion: 2019-01-29
• First posted: 2017-04-14
• Last updated: 2019-01-31

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study