ShuntCheck Performance Characteristics in Asymptomatic Pseudotumor Cerebri Patients

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

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-29

Study Completion Date

2025-01-31

Brief Summary

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The purpose of the study is to determine if the ShuntCheck test can correctly identify flow or no flow in a ventriculoperitoneal shunt in patients with pseudotumor cerebri.

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Detailed Description

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The purpose of the study is to determine if the ShuntCheck test can correctly identify flow or no flow in a ventriculoperitoneal shunt in patients with pseudotumor cerebri.

Flow may be limited due to slit ventricles

Conditions

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Pseudotumor Cerebri

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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ShuntCheck

Participants will be administered the ShuntCheck diagnostic test.

ShuntCheck

Intervention Type DIAGNOSTIC_TEST

The intervention is an FDA-cleared device utilizing a transcutaneous thermal convection to analyze shunt flow.

Interventions

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ShuntCheck

The intervention is an FDA-cleared device utilizing a transcutaneous thermal convection to analyze shunt flow.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* 18 years old or older Adult men or women who possess a VP shunt placed for PTC;
* Capable of providing valid signed informed consent, or has a legal guardian, health care agent, or surrogate decision maker (according to local statutes, and collectively referred to as "surrogates" in this protocol) capable of providing valid, signed informed consent;
* Subjects will be asymptomatic visiting for routine care at 2-4 weeks post op

Exclusion Criteria

* Presence of multiple shunts, or presence of more than one distal shunt catheter (regardless of function) crossing the clavicle ipsilateral to the shunt with suspected obstruction;
* ShuntCheck test would interfere with standard patient care, or emergency shunt surgery that cannot be delayed is indicated;
* Presence of an interfering open wound or edema over any portion of the VP shunt.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No