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Measurements of CSF Shunts and Off-Shunt Locations With Wireless Thermal Anisotropy Measurement Devices | Clinical Trials | Clareo Health

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Measurements of CSF Shunts and Off-Shunt Locations With Wireless Thermal Anisotropy Measurement Devices

Measurements of Cerebrospinal Fluid Shunts and Off-Shunt Locations With Wireless Thermal Anisotropy Measurement Devices

NCT06513572•Rhaeos, Inc.

View on ClinicalTrials.gov

Summary

This study collects data using non-invasive devices for assessing CSF shunt flow using thermal anisotropy measurements in a prospective study setting. The study will collect data to compare measurements from flowing shunts, non-flowing shunts, and off-shunt locations.

Eligibility

Age

All ages

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. At least one existing ventricular CSF shunt, functional or non-functional (including an adjustable valve set to "virtual off," ligated shunt, uncorrected distal catheter disconnection or fracture, distal catheter fragment left in place during shunt surgery, or indication that the shunt is otherwise non-functional), with a region of overlying intact skin appropriate in size for application of the study device
•2. If more than one distal shunt catheter is present, at least one distal shunt catheter is at least 2 cm away from any other distal shunt catheter in the device measurement region
•3. Signed informed consent by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes)
•4. Signed medical records release by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes)
•5. Verbal assent by minors 7 years of age and older who are able to understand the study and communicate their decision

Exclusion Criteria

•1. Presence of an interfering open wound or edema in the FlowSense device measurement area
•2. Patient-reported history of serious adverse skin reactions to silicone-based adhesives
•3. Use of the study device would interfere with standard patient care, or emergency surgery that cannot be delayed, or participation in the study will interfere with, or be detrimental to, administration of optimal healthcare to the subject
•4. Participation in any other investigational procedural, pharmaceutical, and/or device study that may influence the collection of valid data under this study

Locations (8)

CHOC Commerce Tower

Orange, California, United States

Cedars-Sinai Accelerator

West Hollywood, California, United States

Tampa Marriott Water Street

Tampa, Florida, United States

MATTER

Chicago, Illinois, United States

Industrious

Evanston, Illinois, United States

Northwest Special Recreation Association

Rolling Meadows, Illinois, United States

Texas Medical Center Innovation

Houston, Texas, United States

Industrious

Seattle, Washington, United States

Key Dates

Start Date

July 25, 2024

Primary Completion Date

July 27, 2024

Completion Date

July 27, 2024

Last Updated

May 15, 2025

Enrollment

ACTUAL participants

Conditions

Hydrocephalus

Interventions

FlowSense

DEVICE

Crystallization of LA and Adjuvant Mixtures in Cerebrospinal Fluid

NCT07442929

Hydrocephalus

View study

RECRUITING

Neurosurgical Outcome Network

NCT06724029

AneurysmsArteriovenous Malformations+21 more

View study

RECRUITING

Proteinopathies Expression in Skin of Neurodegenerative Disorders

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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Measurements of CSF Shunts and Off-Shunt Locations With Wireless Thermal Anisotropy Measurement Devices

Inclusion Criteria

Exclusion Criteria

Crystallization of LA and Adjuvant Mixtures in Cerebrospinal Fluid

Neurosurgical Outcome Network

Proteinopathies Expression in Skin of Neurodegenerative Disorders

European Study of Prodromal iNPH

The Safety and Efficacy of Rapamycin on Communicating Hydrocephalus Secondary to Intraventricular Hemorrhage

Efficacy in iNPH Shunting (PENS) Trial