Physician Preference Study of ShuntCheck - Madsen
Not Applicable
- Conditions
- CSF Flow Through the Shunt of a Hydrocephalus Patient
- Interventions
- Device: ShuntCheck
- Registration Number
- NCT00583336
- Lead Sponsor
- NeuroDx Development
- 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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Diagnostic ShuntCheck -
- Primary Outcome Measures
Name Time Method ShuntCheck result of "Flow Confirmed" for asymptomatic shunted patients tested Tested in single visit
- Secondary Outcome Measures
Name Time Method ShuntCheck result of "Flow Not Confirmed" for symptomatic shunted patients with shunt obstruction Single visit
Trial Locations
- Locations (1)
Children's Hospital Boston
🇺🇸Boston, Massachusetts, United States