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Assessment of Flow in Cerebrospinal Fluid Shunts With a Wireless Thermal Anisotropy Measurement Device in Asymptomatic Patients

Hydrocephalus Clinical Trial

Official title:
Assessment of Flow in Cerebrospinal Fluid Shunts With a Wireless Thermal Anisotropy Measurement Device in Asymptomatic Patients

Clinical Trial 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).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06410885
Study type Interventional
Source Rhaeos, Inc.
Contact Anna Lisa Somera
Phone 855-814-3569
Email info@rhaeos.com
Status Not yet recruiting
Phase N/A
Start date June 2024
Completion date December 2024
View Details
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