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

NCT06410885 | Not Yet Recruiting FDA Device

• 1 other identifier: 2023-03
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Hydrocephalus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Study device sensitivity, specificity, diagnostic accuracy, and positive predictive value (PPV)

  Up to 7 days

Study Arms (2)

Observational, part 1 (blinded)

EXPERIMENTAL

Device: Thermal Anisotropy Measurement Device

Diagnostic, part 2 (unblinded)

EXPERIMENTAL

Device: Thermal Anisotropy Measurement Device

Interventions

Thermal Anisotropy Measurement Device 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.

Diagnostic, part 2 (unblinded); Observational, part 1 (blinded)

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Existing ventricular cerebrospinal fluid shunt
• Age ≥ 2 years old
• 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
• Capable of providing informed consent or have a legal guardian, health care agent, or surrogate decision-maker able to provide informed consent
• Standard of care outpatient visit with neurosurgeon assessment of having "no clinical concern for shunt malfunction"

You may not qualify if:

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

Sponsors & Collaborators

• Rhaeos, Inc.: lead

Study Sites (1)

UCSF Benioff Children's Hospital

San Francisco, California, 94158, United States

Location

MeSH Terms

Conditions

Hydrocephalus

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Anna Lisa Somera

CONTACT

855-814-3569; info@rhaeos.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2024
• First Posted: May 13, 2024
• Study Start: June 1, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: May 15, 2025

Record last verified: 2025-05

Locations

US (1)