Flow Measurements in Functional CSF Shunts and Off-Shunt Locations with a Second-Generation Thermal Device

Measurements of Flow in Functional Cerebrospinal Fluid Shunts and Off-Shunt Locations 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 functional implanted shunts and off-shunt locations will assess the diagnostic non-inferiority of the second-generation device to the first-generation device.

Study Overview

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

• Study Type: Observational
• Enrollment (Actual): 52

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33602
      • Tampa Marriott Water Street
  • Illinois
    • Chicago, Illinois, United States, 60654
      • Rhaeos, Inc.
    • Rolling Meadows, Illinois, United States, 60008
      • Northwest Special Recreation Association

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. A ventricular CSF shunt with a region of overlying intact skin appropriate in size for application of the study device
2. Signed informed consent by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes)
3. Signed medical records release by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes)
4. 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 study device measurement area
2. Patient-reported history of serious adverse skin reactions to silicone-based adhesives
3. Previous participation in a Rhaeos clinical study in which FlowSense device measurement data were acquired
4. Patient or caregiver report of new or worsening symptoms of a possible shunt malfunction in the prior 7 days
5. 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?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
FlowSense; This study compares the performance of two generations of non-invasive cerebrospinal fluid (CSF) shunt flow assessment devices. Measurements of functional implanted shunts and off-shunt locations will assess the diagnostic non-inferiority of the second-generation device to the first-generation device.	Device: FlowSense; This study compares the performance of two generations of non-invasive cerebrospinal fluid (CSF) shunt flow assessment devices. Measurements of functional implanted shunts and off-shunt locations will assess the diagnostic non-inferiority of the second-generation device to the first-generation device.

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).	Approximately 1 hour
Study Device Specificity	Study device specificity will be calculated as TN / (TN + FP)	Approximately 1 hour

Collaborators and Investigators

• Sponsor: Rhaeos, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2024
• Primary Completion (Actual): July 27, 2024
• Study Completion (Actual): July 27, 2024

Study Registration Dates

• First Submitted: July 23, 2024
• First Submitted That Met QC Criteria: July 23, 2024
• First Posted (Actual): July 29, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 7, 2025
• Last Verified: March 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: 2024-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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