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Assessment of Flow in Cerebrospinal Fluid Shunts With a Second Generation Wireless Thermal Anisotropy Measurement Device | Clinical Trials | Clareo Health

NOT_YET_RECRUITING

Assessment of Flow in Cerebrospinal Fluid Shunts With a Second Generation Wireless Thermal Anisotropy Measurement Device

NCT06409286•Rhaeos, Inc.

View on ClinicalTrials.gov

Summary

This study evaluates the performance of a thermal anisotropy measurement device for non-invasively assessing CSF shunt flow. Patients with an existing implanted shunt and symptoms of shunt malfunction who require shunt revision surgery will be evaluated with the study device to assess flow in CSF shunts as confirmed by surgical outcomes at 7 days. If successful, this study will show that the study device accurately distinguishes between functioning (flowing) and non-functioning (non-flowing) shunts.

Eligibility

Age

All ages

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Existing ventriculoperitoneal CSF shunt on which the subject is dependent
•2. At least one symptom of shunt malfunction as determined by the investigator, such as but not limited to seizure, fever, headache, vision problems, dizziness, disorientation, confusion, vomiting, lethargy, irritability, difficulty waking or staying awake, swelling along shunt tract, enlargement of head, loss of balance, gait disturbance, and loss of sensory or motor function
•3. Exhibit shunt malfunction symptom(s) requiring surgical shunt revision per standard of care assessment without use of device data
•4. Region of intact skin overlying an unambiguously identifiable chronically indwelling ventricular shunt which crosses the clavicle and is appropriate in size for application of the study device
•5. Available for follow-up for up to seven days
•6. Signed informed consent by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes, and collectively referred to as "surrogates" in this protocol)

Exclusion Criteria

•1. Presence of more than one distal shunt catheter in the study device measurement region
•2. Presence of an interfering open wound or edema in the study device measurement area
•3. Subject-reported history of adverse skin reactions to adhesives
•4. Investigator judges that the subject is likely to be lost to follow-up due to unavailability or clinical outcome being unobtainable
•5. Participation in the study will interfere with, or be detrimental to, administration of optimal health-care to the subject
•6. Previous participation in a Rhaeos clinical study in which FlowSense device measurement data were acquired
•7. Participation in any other investigational procedural, pharmaceutical, and/or device study that may influence the collection of valid data under this study

Locations (1)

Washington University in St. Louis

St Louis, Missouri, United States

Key Dates

Start Date

July 1, 2025

Primary Completion Date

December 1, 2025

Completion Date

December 1, 2025

Last Updated

May 15, 2025

Enrollment

ESTIMATED participants

Conditions

Hydrocephalus

Interventions

Thermal Anisotropy Measurement Device

DEVICE

Contacts

Anna Lisa Somera

CONTACT

855-814-3569 info@rhaeos.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 15, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Assessment of Flow in Cerebrospinal Fluid Shunts With a Second Generation Wireless Thermal Anisotropy Measurement Device

Inclusion Criteria

Exclusion Criteria

Crystallization of LA and Adjuvant Mixtures in Cerebrospinal Fluid

Neurosurgical Outcome Network

Proteinopathies Expression in Skin of Neurodegenerative Disorders

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