Functional and Non-Functional CSF Shunt Flow Measured With a Second-Generation Wireless Thermal Device

Measurements of Flow in Functional and Non-Functional Cerebrospinal Fluid Shunts With a Second-Generation Wireless Thermal Anisotropy Measurement Device

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

Study Overview

• Status: Terminated
• Conditions: Hydrocephalus
• Intervention / Treatment: Device: FlowSense

• Study Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• United States
  • California
    • Orange, California, United States, 92868
      • CHOC Commerce Tower
    • West Hollywood, California, United States, 90048
      • Cedars-Sinai Accelerator
  • Florida
    • Tampa, Florida, United States, 33602
      • Tampa Marriott Water Street
  • Illinois
    • Chicago, Illinois, United States, 60611
      • MATTER
    • Evanston, Illinois, United States, 60201
      • Industrious
    • Rolling Meadows, Illinois, United States, 60008
      • Northwest Special Recreation Association
  • Texas
    • Houston, Texas, United States, 77021
      • Texas Medical Center Innovation
  • Washington
    • Seattle, Washington, United States, 98015
      • Industrious

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Pediatric and adult patients with an existing ventricular shunt will be enrolled in this study.

Description

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 adverse skin reactions to adhesives
3. Previous participation in a Rhaeos clinical study in which FlowSense device measurement data were acquired
4. New or worsening symptoms of a possible shunt malfunction in the prior 7 days
5. 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
6. Participation in any other investigational procedural, pharmaceutical, and/or device study that may influence the collection of valid data under this study

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Study Device Sensitivity	Study device sensitivity will be calculated as TP / (TP + FN).	Up to 1 hour
Study Device Specificity	Study device specificity will be calculated as TN / (TN + FP)	Up to 1 hour

Collaborators and Investigators

• Sponsor: Rhaeos, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 27, 2024
• Primary Completion (Actual): July 27, 2024
• Study Completion (Actual): July 27, 2024

Study Registration Dates

• First Submitted: July 11, 2024
• First Submitted That Met QC Criteria: July 11, 2024
• First Posted (Actual): July 17, 2024

Study Record Updates

• Last Update Posted (Actual): May 15, 2025
• Last Update Submitted That Met QC Criteria: May 12, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hydrocephalus
• Other Study ID Numbers: 2024-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No