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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40+
SponsorUniversity of South Florida

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • ShuntCheck

Treatment groups

50 Participants
are divided into 1 treatment group

Sponsors and collaborators

University of South Florida

Lead sponsor

NeuroDx Development

Collaborator