Clinical Research Directory
Browse clinical research sites, groups, and studies.
Assessment of Flow in Cerebrospinal Fluid Shunts With a Wireless Thermal Anisotropy Measurement Device in Asymptomatic Patients
Sponsor: Rhaeos, Inc.
Summary
This study evaluates the performance of the study device, FlowSense®, a sensor for non-invasively assessing cerebrospinal fluid (CSF) shunt flow. Subjects with an existing implanted ventricular CSF shunt will be evaluated with the study device in an outpatient setting to determine the negative predictive value (NPV; Part 1, blinded) and explore changes in surveillance imaging, health resource utilization, and visit duration during routine follow-up visits (Part 2, unblinded).
Key Details
Gender
All
Age Range
2 Years - Any
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2025-06
Completion Date
2026-05
Last Updated
2025-05-15
Healthy Volunteers
No
Conditions
Interventions
Thermal Anisotropy Measurement Device
The study device is a non-invasive sensor that is placed on the study subject's skin overlying an existing implanted CSF shunt. It uses an integrated thermal actuator and temperature sensors to assess shunt flow.
Locations (1)
UCSF Benioff Children's Hospital
San Francisco, California, United States