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

Stopped early · Not applicable

Conditions studied: Hydrocephalus, Hydrocephalus in Children, Tumor, Brain, Subarachnoid Hemorrhage

In brief

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

Key facts

Study ID

NCT03471702

Run by

Aqueduct Critical Care

People needed

12

Starts

2018-02-28

Expected to finish

2018-11-01

Last updated by the study team

2019-07-11

Who can join

Age: any, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject scheduled to have an external drain (includes extra-ventricular and lumbar drains) placed as part of routine management.
• Age 0-80.
• Able to obtain consent or legally authorized representative (LAR) consents for subject to be treated on study.

You may not qualify if…

• Anticoagulant therapy (does not include DVT or PE prophylaxis).
• Known bleeding diathesis.
• Scalp infection.
• In the opinion of the Investigator the subject is not a good study candidate.

Where it is running

• 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

Full record on ClinicalTrials.gov

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