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

Recruiting now

Conditions studied: Hydrocephalus, Normal Pressure

In brief

The purpose of this study is to assess the diagnostic accuracy of ShuntCheck compared with radionuclide shunt patency testing (SPS) to detect CSF shunt flow of NPH patients with suspected shunt obstruction.

Key facts

Study ID

NCT04309487

Run by

University of South Florida

People needed

20

Starts

2020-01-24

Expected to finish

2027-01-01

Last updated by the study team

2026-05-18

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• University of South Florida Department of Neurological Surgery and Brain Repair — Tampa, Florida, United States (enrolling)

Full record on ClinicalTrials.gov

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