ShuntCheck Performance in Asymptomatic Normal Pressure Hydrocephalus

This study is looking at how well a device called ShuntCheck works. ShuntCheck is an FDA-cleared device that checks if a shunt (a tube that drains fluid from the brain) is working properly. The study wants to see if ShuntCheck can accurately tell if fluid is flowing through the shunt in people who have normal pressure hydrocephalus (a condition where too much fluid builds up in the brain) but are not currently having symptoms. You can join if you are 40 years or older, have a ventriculoperitoneal shunt (a specific type of shunt) for normal pressure hydrocephalus, and are visiting for routine care. The study will measure how accurately ShuntCheck identifies when a shunt is working or not working. The current recruitment status is unclear.

Study design
This is an observational study, meaning researchers will observe without giving new treatments. It plans to include 50 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The main measurements are taken at 15 minutes.

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NCT04011566

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

Recruiting
Not specifiedAges 40+Observational
University of South Florida
~50 participants
Updated 2026-05-19 on ClinicalTrials.gov
What's tested:ShuntCheck

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Specificity of ShuntCheck test
Measured over 15 minutes
+1 more outcome measured
Hydrocephalus, Normal Pressure
1 sites across 1 states
Florida1
  • Naomi Abel, MD · PRINCIPAL_INVESTIGATOR · University of South Florida

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Eligibility criteria

Inclusion

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

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.
  • Specificity of ShuntCheck test15 minutes
  • Negative Predictive Value of ShuntCheck test15 minutes