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ShuntCheck for Normal Pressure Hydrocephalus

This study is looking at how well a device called ShuntCheck works to find out if a shunt (a tube that drains fluid from the brain) is blocked in people with Normal Pressure Hydrocephalus (NPH). NPH is a condition where too much fluid builds up in the brain. ShuntCheck uses a special heat-based technology to check the shunt flow. Researchers want to see if ShuntCheck is as accurate as another test called radionuclide shunt patency testing. You might be able to join if you are 40 or older, have a VP shunt for NPH, and your doctor thinks your shunt might be blocked. The study will measure how good ShuntCheck is at correctly identifying blocked or unblocked shunts. The current status of this study is unclear, and it plans to enroll 20 participants.

Study design
This is an observational study, meaning researchers will observe and compare the results of two diagnostic tests. It plans to include 20 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints are measured at 15 minutes and 60 minutes after the ShuntCheck test.

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NCT04309487

Diagnostic Accuracy of ShuntCheck Compared to Radionuclide Shunt: Patency in Patients With Normal Pressure Hydrocephalus

Recruiting
Not specifiedAges 40+Observational
University of South Florida
~20 participants
Updated 2026-05-18 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
Sensitivity of ShuntCheck compared to radionuclide shunt patency study
Measured over 15 minutes
+1 more outcome measured

Conditions

Hydrocephalus, Normal Pressure

Explore related trials

Normal pressure hydrocephalus

Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • Naomi Abel, MD · PRINCIPAL_INVESTIGATOR · University of South Florida

Who to contact

Naomi Abel, MD
[email protected]
813 259-0904
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Men or women 40 yo or older and have a VP shunt placed for NPH and are suspected of shunt obstruction.
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

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 VP shunt.

What this trial measures

  • Sensitivity of ShuntCheck compared to radionuclide shunt patency study15 minutes
  • Negative Predictive Value of ShuntCheck compared to radionuclide shunt patency study60 Minutes