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NCT Number: NCT06410885

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).

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Key information

Conditions

Hydrocephalus Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

2 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCSF Benioff Children's Hospital

San Francisco, California, 94158, United States

Location contact

Catalina Pen

CONTACT

[email protected]

415-353-2342

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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"

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Study device negative predictive value (NPV)

    Time frame: Up to 7 days

    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.

Secondary outcomes

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

    Time frame: Up to 7 days

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Anna Lisa Somera

CONTACT

[email protected]

855-814-3569

Sponsors and collaborators

Lead sponsor

Rhaeos, Inc.

Industry

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 13, 2024
Registry last updated
May 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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