Physician Preference Study of ShuntCheck - Madsen

NeuroDx Development

Status: Unknown

Conditions: CSF Flow Through the Shunt of a Hydrocephalus Patient

Treatments: Device: ShuntCheck

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00583336

NDX 07-07-0277

07-07-0277

Details and patient eligibility

About

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)

Enrollment: 200 estimated patients

Sex: All

Ages: Under 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Diagnostic

Experimental group

Treatment:

Device: ShuntCheck