Actively Recruiting
Assessment of ShuntCheck Performance Characteristics in Asymptomatic Patients With Normal Pressure Hydrocephalus
Led by University of South Florida · Updated on 2026-05-19
50
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 ability of the ShuntCheck test to detect flow or no flow in ventriculoperitoneal shunts among patients with asymptomatic normal pressure hydrocephalus. This observational study aims to determine the test's accuracy in identifying shunt function without symptoms, providing important information for routine care. Participants will undergo the ShuntCheck diagnostic test, which uses an FDA-cleared device that analyzes shunt flow through transcutaneous thermal convection. The study involves a single testing approach, with some assessments measuring the test performed twice to evaluate specificity and negative predictive value. During the study, participants will be monitored through the ShuntCheck test and routine clinical visits. Researchers will measure the specificity and negative predictive value of the test at 15 minutes and also assess these outcomes when the test is performed twice at 60 minutes. The study is sponsored by the University of South Florida and continues until November 2026.
CONDITIONS
Brief Title
Assessment of ShuntCheck Performance Characteristics in Asymptomatic Patients With Normal Pressure Hydrocephalus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Asymptomatic men or women 40 years old or older with a ventriculoperitoneal shunt placed for normal pressure hydrocephalus visiting for routine care
- Able to provide valid signed informed consent, or has a legal guardian, health care agent, or surrogate decision maker who can provide 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 shunt with suspected obstruction
- ShuntCheck test would interfere with standard patient care or emergency shunt surgery that cannot be delayed is needed
- Presence of an open wound or swelling over any part of the ventriculoperitoneal 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 - Up to 1 hour
Participants receive the ShuntCheck diagnostic test to assess shunt flow using a non-invasive device.
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
R
Rachel Karlnoski, 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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