Flow Measurements in Functional CSF Shunts and Off-Shunt Locations with a Second-Generation Thermal Device

CompletedOBSERVATIONAL
Enrollment

52

Participants

Timeline

Start Date

July 25, 2024

Primary Completion Date

July 27, 2024

Study Completion Date

July 27, 2024

Conditions
Hydrocephalus
Interventions
DEVICE

FlowSense

This study compares the performance of two generations of non-invasive cerebrospinal fluid (CSF) shunt flow assessment devices. Measurements of functional implanted shunts and off-shunt locations will assess the diagnostic non-inferiority of the second-generation device to the first-generation device.

Trial Locations (3)

33602

Tampa Marriott Water Street, Tampa

60008

Northwest Special Recreation Association, Rolling Meadows

60654

Rhaeos, Inc., Chicago

All Listed Sponsors
lead

Rhaeos, Inc.

INDUSTRY