This record was last updated May 15, 2025 (before its estimated May 2026 completion). Its status may not reflect the trial's current state.
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).
Protocol Amendment History
3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2024-05-07; most recent amendment 2025-05-12.