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

NCT03471702 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2019-07-11

No results posted yet for this study

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

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Aqueduct Critical Care

    lead INDUSTRY

Principal Investigators

  • Sam Browd, MD, PhD · Aqueduct Critical Care, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-28
Primary Completion
2018-11-01
Completion
2018-11-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03471702 on ClinicalTrials.gov