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Assessment of CSF Shunt Flow With Thermal Measurements B — STEALTH  

Hydrocephalus Clinical Trial

Official title:
Assessment of Flow in Cerebrospinal Fluid Shunts With a Wireless Thermal Anisotropy Measurement Device, Phase B

Clinical Trial Summary

This study evaluates the performance of a non-invasive thermal measurement device for assessing CSF shunt flow. Patients with an existing implanted shunt and symptoms of shunt malfunction will be evaluated with the study device.

Clinical Trial Description

Patients with an existing implanted ventriculoperitoneal (VP) shunt and who are experiencing shunt malfunction symptoms will be recruited by the clinical investigators at each investigational site in accordance with the inclusion and exclusion criteria. Assessment of shunt flow will be performed non-invasively with the study device; physician and clinical staff will be blinded to the device result. Standard-of-care assessment of shunt function will be performed and surgical intervention will occur based on the judgement of the treating neurosurgeon without the use of study device data. This trial will evaluate the ability of the study device to identify shunt malfunctions. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05432986
Study type Observational
Source Rhaeos, Inc.
Contact
Status Completed
Phase
Start date July 7, 2022
Completion date November 10, 2023
View Details
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