Assessment of ShuntCheck Performance Characteristics in Asymptomatic Patients With Normal Pressure Hydrocephalus

  • STATUS
    Recruiting
  • End date
    Jan 16, 2025
  • participants needed
    20
  • sponsor
    University of South Florida
Updated on 16 June 2022

Summary

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 asymptomatic normal pressure hydrocephalus.

Details
Condition Hydrocephalus, Normal Pressure
Treatment ShuntCheck
Clinical Study IdentifierNCT04011566
SponsorUniversity of South Florida
Last Modified on16 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Asymptomatic men or women 40 years old or older and have a ventriculoperitoneal shunt placed for normal pressure hydrocephalus and are visiting for routine care
Capable of providing valid signed informed consent, or has a legal guardian, health care agent, or surrogate decision maker capable of providing valid, signed informed consent

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 ventriculoperitoneal shunt
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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