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

NCT ID: NCT06410885

Last Updated: 2025-05-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-30
• Study Completion Date: 2026-05-31

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Observational, part 1 (blinded)

Group Type: EXPERIMENTAL

Thermal Anisotropy Measurement Device

Intervention Type: 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)

Group Type: EXPERIMENTAL

Thermal Anisotropy Measurement Device

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 2 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rhaeos, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

UCSF Benioff Children's Hospital

San Francisco, California, United States

Countries

United States

Central Contacts

Anna Lisa Somera

Role: CONTACT

info@rhaeos.com

855-814-3569

Facility Contacts

Catalina Pen

Role: primary

catalina.pen@ucsf.edu

415-353-2342

Other Identifiers

2023-03

Identifier Type: -

Identifier Source: org_study_id