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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06524492

Enrollment

Registered

2024-07-29

Start date

2024-07-25

Completion date

2024-07-27

Last updated

2025-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hydrocephalus

Brief summary

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.

Interventions

DEVICEFlowSense

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026