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Wireless sensor to check fluid flow in brain shunts for hydrocephalus

Tests FlowSense, a skin sensor, to check shunt flow in people with hydrocephalus.

Key facts

Who runs it
Rhaeos, Inc.
Where
San Francisco, United StatesSee the site
Trial code
Registry title
Assessment of Flow in Cerebrospinal Fluid Shunts With a Wireless Thermal Anisotropy Measurement Device in Asymptomatic Patients
Status
Not yet recruiting
People taking part
60 people, planned
Started
Jun 2025
Planned end
May 2026
Type of study
Interventional, 2 groups
Treatments tested
  • Thermal Anisotropy Measurement Device
Record updated
15 May 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for people with hydrocephalus who already have a ventricular cerebrospinal fluid shunt and no signs of shunt problems. It tests a skin sensor that checks shunt flow.

Age
2 years and older.
Sex
All sexes can join.
Disease stage
Hydrocephalus with an existing ventricular shunt. At a routine clinic visit, the neurosurgeon must see no clinical concern for shunt malfunction.
Earlier treatment
Must already have a long-standing ventricular shunt that can be felt under intact skin where it crosses the collarbone.

Main reasons for not taking part

  • Not scheduled for routine imaging (CT, MRI, X-ray shunt series) at the clinic visit.
  • More than one lower shunt tube in the area the device measures.
  • An open wound or swelling in the measurement area.
  • Past skin reactions to silicone adhesives.
  • Not available for the seven-day follow-up.

The registry criteria, word for word

Show all 11 criteriaShow less

Who can take part

  • 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"

Who cannot take part

  • Subject-reported history of adverse skin reactions to silicone adhesives
  • 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
  • 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

Where in United States

  • UCSF Benioff Children's HospitalSan Francisco, United StatesContact: Catalina PenNot yet recruiting

About the trial

What the trial wants to find out

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).

The 2 groups in the trial

  • Observational, part 1 (blinded)Treatment being tested

    Treatment: Thermal Anisotropy Measurement Device

  • Diagnostic, part 2 (unblinded)Treatment being tested

    Treatment: Thermal Anisotropy Measurement Device

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Assessment of Flow in Cerebrospinal Fluid Shunts With a Wireless Thermal Anisotropy Measurement Device in Asymptomatic Patients
Plain-language title
Wireless sensor to check fluid flow in brain shunts for hydrocephalusGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
15 May 2025