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Clinical Trials in the USA / NCT06410885
Starting soon Not applicable

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

NCT06410885 · tracked via the Priya Life Science USA tracker
Sponsor
Rhaeos, Inc
Phase
Not applicable
Started
2025-06
Last updated
2025-05-15

Condition(s) studied

Hydrocephalus

Investigational drug(s) / intervention(s)

Thermal Anisotropy Measurement 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.

Study 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).

Eligibility

Sex
ALL
Min age
2 Years
Max age
—
Healthy volunteers
No
Inclusion criteria 1. Existing ventricular cerebrospinal fluid shunt 2. Age ≥ 2 years old 3. Region of intact skin overlying an unambiguously identifiable palpable chronically indwelling ventricular shunt that crosses the clavicle; region of skin is appropriate in size for application of the study device 4. Capable of providing informed consent or have a legal guardian, health care agent, or surrogate decision-maker able to provide informed consent 5. Standard of care outpatient visit with neurosurgeon assessment of having "no clinical concern for shunt malfunction" Exclusion criteria 1. Subject not scheduled to receive outpatient standard of care imaging (CT, MRI, X-ray shunt series) as part of the clinic visit 2. Presence of more than one distal shunt catheter in the study device measurement region 3. Presence of an interfering open wound or edema in the study device measurement region 4. Subject-reported history of adverse skin reactions to silicone adhesives 5. Participation in the study will interfere with, or be detrimental to, the administration of optimal health care to the subject 6. Subject not available for seven-day follow-up

Primary outcome measure(s)

  • 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.

Trial sites (1)

FacilityCityRegionStatus
UCSF Benioff Children's Hospital San Francisco California

More Rhaeos, Inc. trials in the USA

Assessment of CSF Shunt Flow and Headaches With a Thermal Measurement Device Recruiting
Longitudinal Measurements of Flow in Cerebrospinal Fluid Shunts With a Wireless Thermal Anisotropy Measurement Device Recruiting
Assessment of CSF Shunt Flow During Activities of Daily Living and Sleep With a Thermal Measurement Device Recruiting
Study of Shunt Flow Under Different Valve Settings Using a Wireless Sensor Starting soon
Formative Usability Assessment of Wireless Thermal Anisotropy Devices Recruiting

Other trials for the same condition

Assessment of CSF Shunt Flow and Headaches With a Thermal Measurement Device Recruiting
Longitudinal Measurements of Flow in Cerebrospinal Fluid Shunts With a Wireless Thermal Anisotropy Measurement Device Recruiting
Assessment of CSF Shunt Flow During Activities of Daily Living and Sleep With a Thermal Measurement Device Recruiting
Study of Shunt Flow Under Different Valve Settings Using a Wireless Sensor Starting soon
Formative Usability Assessment of Wireless Thermal Anisotropy Devices Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06410885 on ClinicalTrials.gov ↗ ← All trials in the USA