Assessment of Flow in Cerebrospinal Fluid Shunts With a Wireless Thermal Anisotropy Measurement Device in Asymptomatic Patients

This study evaluates the performance of the study device, FlowSense®, a sensor for non-invasively assessing cerebrospinal fluid (CSF) shunt flow. Subjects with an existing implanted ventricular CSF shunt will be evaluated with the study device in an outpatient setting to determine the negative predictive value (NPV; Part 1, blinded) and explore changes in surveillance imaging, health resource utilization, and visit duration during routine follow-up visits (Part 2, unblinded).

Study Overview

• Status: Not yet recruiting
• Conditions: Hydrocephalus
• Intervention / Treatment: Device: Thermal Anisotropy Measurement Device

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anna Lisa Somera; Phone Number: 855-814-3569; Email: info@rhaeos.com

Participation Criteria

Eligibility Criteria

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

Description

Inclusion criteria

1. Existing ventricular cerebrospinal fluid shunt
2. Age ≥ 2 years old
3. Region of intact skin overlying an unambiguously identifiable palpable chronically indwelling ventricular shunt that crosses the clavicle; region of skin is appropriate in size for application of the study device
4. Capable of providing informed consent or have a legal guardian, health care agent, or surrogate decision-maker able to provide informed consent
5. Standard of care outpatient visit with neurosurgeon assessment of having "no clinical concern for shunt malfunction"

Exclusion criteria

1. Subject not scheduled to receive outpatient standard of care imaging (CT, MRI, X-ray shunt series) as part of the clinic visit
2. Presence of more than one distal shunt catheter in the study device measurement region
3. Presence of an interfering open wound or edema in the study device measurement region
4. Subject-reported history of adverse skin reactions to silicone adhesives
5. Participation in the study will interfere with, or be detrimental to, the administration of optimal health care to the subject
6. Subject not available for seven-day follow-up

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Observational, part 1 (blinded)	Device: Thermal Anisotropy Measurement Device; The study device is a non-invasive sensor that is placed on the study subject's skin overlying an existing implanted CSF shunt. It uses an integrated thermal actuator and temperature sensors to assess shunt flow.
Experimental: Diagnostic, part 2 (unblinded)	Device: Thermal Anisotropy Measurement Device; The study device is a non-invasive sensor that is placed on the study subject's skin overlying an existing implanted CSF shunt. It uses an integrated thermal actuator and temperature sensors to assess shunt flow.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Study device negative predictive value (NPV)	The study device will produce either "flow confirmed" or "flow not confirmed" data in a blinded fashion. Ground truth will be established based on 7-day follow-up an intraoperative observations for any surgery performed per the standard of care.	Up to 7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Study device sensitivity, specificity, diagnostic accuracy, and positive predictive value (PPV)	The study device will produce either "flow confirmed" or "flow not confirmed" data in a blinded fashion. Ground truth will be established based on 7-day follow-up an intraoperative observations for any surgery performed per the standard of care.	Up to 7 days

Collaborators and Investigators

• Sponsor: Rhaeos, Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: May 3, 2024
• First Submitted That Met QC Criteria: May 7, 2024
• First Posted (Actual): May 13, 2024

Study Record Updates

• Last Update Posted (Actual): May 13, 2024
• Last Update Submitted That Met QC Criteria: May 7, 2024
• Last Verified: May 1, 2024

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: 2023-03

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