NCT00583336UnknownNot Applicable
Physician Preference Study of the Utility of ShuntCheck to Detect Cerebrospinal Fluid (CSF) in Patients With Ventriculo-Peritoneal CSF Shunts
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- NeuroDx Development
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- ShuntCheck result of "Flow Confirmed" for asymptomatic shunted patients tested
Study Overview
Brief Summary
ShuntCheck can be used to detect CSF flow in asymptomatic hydrocephalus patients and can be used to detect no-flow in symptomatic patients with shunt obstruction.
Secondarily, the ShuntCheck test will yield the clearest results when patients are tested sitting up (or alternatively while supine)
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- — to 85 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subjects must be 0 - 85 years of age, of any race or sex with parent consent for minors
- •Subjects must have a chronically indwelling ventriculo-peritoneal shunt that is palpable along the clavicle.
- •Subjects must be physically stable as determined by the physician.
Exclusion Criteria
- •Subjects with the presence of an open wound at the shunt site that could interfere with the collection of ShuntCheck data.
- •Subjects unable to lie supine with head elevated 30 degrees or less
- •Subjects who have had shunt surgery within two weeks.
- •Inability or unwillingness of subject to endure the test.
- •Other judgments of the investigator.
Arms & Interventions
Diagnostic
Experimental
Intervention: ShuntCheck (Device)
Outcomes
Primary Outcomes
ShuntCheck result of "Flow Confirmed" for asymptomatic shunted patients tested
Time Frame: Tested in single visit
Secondary Outcomes
- ShuntCheck result of "Flow Not Confirmed" for symptomatic shunted patients with shunt obstruction(Single visit)
Investigators
Study Sites (1)
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