CSF Flow Through the Shunt of a Hydrocephalus Patient
Conditions
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)
Interventions
DEVICEShuntCheck
Thermal dilution test for CSF flow
Sponsors
Boston Children's Hospital
NeuroDx Development
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Subjects must be 0 - 85 years of age, of any race or sex with parent consent for minors 2. Subjects must have a chronically indwelling ventriculo-peritoneal shunt that is palpable along the clavicle. 3. Subjects must be physically stable as determined by the physician.
Exclusion criteria
1. Subjects with the presence of an open wound at the shunt site that could interfere with the collection of ShuntCheck data. 2. Subjects unable to lie supine with head elevated 30 degrees or less 3. Subjects who have had shunt surgery within two weeks. 4. Inability or unwillingness of subject to endure the test. 5. Other judgments of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ShuntCheck result of Flow Confirmed for asymptomatic shunted patients tested | Tested in single visit |
Secondary
| Measure | Time frame |
|---|---|
| ShuntCheck result of Flow Not Confirmed for symptomatic shunted patients with shunt obstruction | Single visit |
Countries
United States
Contacts
Primary ContactJoseph R Madsen, MD
Outcome results
None listed