Physician Preference Study of ShuntCheck

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2015-09-30

Brief Summary

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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)

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Detailed Description

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Conditions

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CSF Flow Through the Shunt of a Hydrocephalus Patient

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Diagnostic

Group Type EXPERIMENTAL

ShuntCheck

Intervention Type DEVICE

Thermal dilution test for CSF flow

Interventions

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ShuntCheck

Thermal dilution test for CSF flow

Intervention Type DEVICE

Eligibility Criteria

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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.

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No