CRT ShuntCheck "Fit & Function" Study
Status unconfirmed · Not applicable
Conditions studied: Hydrocephalus
In brief
An exploratory "Fit \& Function" study of Continuous Real Time (CRT) ShuntCheck, a non-invasive method for monitoring changes in cerebrospinal fluid (CSF) shunt flow in hydrocephalus patients. The device will be tested on 10 pediatric patients (at Johns Hopkins Hospital) and 10 adult patients (at LifeBridge Health) and results will be used to optimize device design.
Key facts
- Study ID
- NCT02067364
- Run by
- NeuroDx Development
- People needed
- 20
- Starts
- 2014-01-01
- Expected to finish
- 2015-08-01
- Last updated by the study team
- 2015-06-23
Who can join
Age: 3 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- For the pediatric subjects, males or females, older than three and less than 20 years of age.
- For the adult subjects, males or females, older than 35 years of age
- Parent/guardian or alert subject (age 18 or over) capable of giving consent; subject less than 18 and of assent age must give assent to participate if appropriate and required by the institution. If the subjects are incapable of giving assent, then only parent/guardian consent is required.
- Possess an unambiguously identifiable chronically indwelling ventricular shunt which crosses the clavicle.
You may not qualify if…
- Inability or unwillingness of the parent/guardian or alert subject to give informed consent/assent (when appropriate) as required by the Institutional Review Board.
- Study testing would interfere with emergent subject care or if the subject is scheduled to go the OR in short order.
- Presence of an interfering open wound or edema over the shunt.
Where it is running
- LifeBridge Health, Sinai Hospital of Baltimore (Testing Adult Patients 35 years+) — Baltimore, Maryland, United States (enrolling)
- Johns Hopkins Hospital (Testing Pediatric Patients Age 3 to 19) — Baltimore, Maryland, United States (enrolling)
Full record on ClinicalTrials.gov
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