Assessment of Flow in Cerebrospinal Fluid Shunts With a Wireless Thermal Anisotropy Measurement Device in Asymptomatic Patients - Trial NCT06410885
Access comprehensive clinical trial information for NCT06410885 through Pure Global AI's free database. This phase not specified trial is sponsored by Rhaeos, Inc. and is currently Not yet recruiting. The study focuses on Hydrocephalus. Target enrollment is 60 participants.
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Study Focus
Sponsor & Location
Rhaeos, Inc.
Timeline & Enrollment
N/A
Jun 01, 2024
Dec 01, 2024
Primary Outcome
Study device negative predictive value (NPV)
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).
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06410885
Device Trial