Actively Recruiting
Diagnostic Accuracy of ShuntCheck Compared With Radionuclide Shunt Patency Test to Detect Shunt Flow Obstruction in Patients With Normal Pressure Hydrocephalus
Led by University of South Florida · Updated on 2026-05-18
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of South Florida
Lead Sponsor
N
NeuroDx Development
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the diagnostic accuracy of a device called ShuntCheck compared to radionuclide shunt patency testing in patients with Normal Pressure Hydrocephalus (NPH) who are suspected of having a shunt obstruction. The study aims to determine how well ShuntCheck detects cerebrospinal fluid (CSF) shunt flow issues in this patient group. Participants will undergo the ShuntCheck diagnostic test, which is an FDA-cleared device that uses transcutaneous thermal convection to analyze shunt flow. This test is non-invasive and designed to assess whether the shunt is functioning properly without the need for radionuclide imaging. During the study, researchers will measure the sensitivity and negative predictive value of ShuntCheck compared to the radionuclide shunt patency study, with assessments at 15 minutes and 60 minutes respectively. Participants must be adults aged 40 or older with a ventriculoperitoneal (VP) shunt for NPH and suspected obstruction. The study involves informed consent, and safety exclusions are in place to ensure that the test does not interfere with urgent medical care or existing wounds.
CONDITIONS
Brief Title
Diagnostic Accuracy of ShuntCheck Compared to Radionuclide Shunt: Patency in Patients With Normal Pressure Hydrocephalus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men or women 40 years or older
- Have a ventriculoperitoneal (VP) shunt placed for Normal Pressure Hydrocephalus
- Suspected of shunt obstruction
- Able to provide valid signed informed consent or have a legal guardian or surrogate able to consent
You will not qualify if you...
- Presence of multiple shunts or more than one distal shunt catheter crossing the clavicle on the same side as the suspected obstruction
- ShuntCheck test would interfere with standard patient care or emergency shunt surgery cannot be delayed
- Presence of an open wound or swelling over any part of the VP shunt
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 1 hour
Participants undergo the ShuntCheck diagnostic test and radionuclide shunt patency study to detect shunt flow obstruction.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
University of South Florida Department of Neurological Surgery and Brain Repair
Tampa, Florida, United States, 33606
Actively Recruiting
Research Team
N
Naomi Abel, MD
T
Thanh Tran, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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