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

Not Applicable

Not yet recruiting

• Conditions: Hydrocephalus
• Interventions: Device: Thermal Anisotropy Measurement Device

• Registration Number: NCT06410885
• Lead Sponsor: Rhaeos, Inc.

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-05-03
• Study First Submitted QC: 2024-05-07
• Study First Posted: 2024-05-13
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-15
• Study Start: 2025-06
• Primary Completion: 2026-05
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Observational, part 1 (blinded)	Thermal Anisotropy Measurement Device	-
Diagnostic, part 2 (unblinded)	Thermal Anisotropy Measurement Device	-

Primary Outcome Measures

Name	Time	Method
Study device negative predictive value (NPV)	Up to 7 days	The study device will produce either "flow confirmed" or "flow not confirmed" data in a blinded fashion. Ground truth will be established based on 7-day follow-up an intraoperative observations for any surgery performed per the standard of care.

Secondary Outcome Measures

Name	Time	Method
Study device sensitivity, specificity, diagnostic accuracy, and positive predictive value (PPV)	Up to 7 days	The study device will produce either "flow confirmed" or "flow not confirmed" data in a blinded fashion. Ground truth will be established based on 7-day follow-up an intraoperative observations for any surgery performed per the standard of care.

Trial Locations

Locations (1)

UCSF Benioff Children's Hospital; 🇺🇸 San Francisco, California, United States