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NOT YET RECRUITING
NCT06410885
NA

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

Sponsor: Rhaeos, Inc.

View on ClinicalTrials.gov

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).

Key Details

Gender

All

Age Range

2 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2025-06

Completion Date

2026-05

Last Updated

2025-05-15

Healthy Volunteers

No

Conditions

Interventions

DEVICE

Thermal Anisotropy Measurement Device

The study device is a non-invasive sensor that is placed on the study subject's skin overlying an existing implanted CSF shunt. It uses an integrated thermal actuator and temperature sensors to assess shunt flow.

Locations (1)

UCSF Benioff Children's Hospital

San Francisco, California, United States