Physician Preference Study of the Utility of ShuntCheck to Detect Cerebrospinal Fluid (CSF) in Patients With Ventriculo-Peritoneal CSF Shunts

NeuroDx Development1 site in 1 country200 target enrollmentSeptember 2007

ConditionsCSF Flow Through the Shunt of a Hydrocephalus Patient

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: CSF Flow Through the Shunt of a Hydrocephalus Patient
Sponsor: NeuroDx Development
Enrollment: 200
Locations: 1
Primary Endpoint: ShuntCheck result of "Flow Confirmed" for asymptomatic shunted patients tested
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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)

Registry

clinicaltrials.gov

Start Date

September 2007

End Date

September 2015

Last Updated

10 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

NeuroDx Development

Responsible Party

Sponsor

Eligibility Criteria

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.