NCT05432986

Assessment of CSF Shunt Flow With Thermal Measurements B

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 141 (actual)
• Sponsor: Rhaeos, Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Hydrocephalus

Interventions

Type	Name	Description
DEVICE	Thermal Anisotropy Measurement Device	A wireless device for non-invasively assessing CSF shunt flow.

Timeline

• Start date: 2022-07-07
• Primary completion: 2023-11-03
• Completion: 2023-11-10
• First posted: 2022-06-27
• Last updated: 2025-02-20
• Results posted: 2025-01-30

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated device study