Assessment of CSF Shunt Flow With Thermal Measurements

  • STATUS
    Recruiting
  • participants needed
    40
  • sponsor
    Rhaeos, Inc.
Updated on 2 July 2022

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.

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 in need of surgical revision.

Details
Condition Hydrocephalus
Treatment Thermal Anisotropy Measurement Device
Clinical Study IdentifierNCT05015751
SponsorRhaeos, Inc.
Last Modified on2 July 2022

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