Status:
TERMINATED
A Secondary Study Evaluating Aqueduct's Smart External Drain (SED)
Lead Sponsor:
Aqueduct Critical Care
Conditions:
Hydrocephalus
Hydrocephalus in Children
Eligibility:
All Genders
Up to 80 years
Phase:
NA
Brief 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...
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. Su...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
February 28 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2018
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03471702
Start Date
February 28 2018
End Date
November 1 2018
Last Update
July 11 2019
Active Locations (3)
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1
Texas Children's Hospital
Houston, Texas, United States, 77030
2
Seattle Children's Hospital
Seattle, Washington, United States, 98105
3
University of Washington School of Medicine, Harborview Medical Center
Seattle, Washington, United States, 98195