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Wireless skin sensor to detect fluid flow in hydrocephalus shunts

Tests a wireless skin sensor for detecting flow in shunts of people with hydrocephalus.

Key facts

Who runs it
Rhaeos, Inc.
Where
Peoria, United StatesSee the site
Trial code
Registry title
Flow Detection in Open and Closed Shunt Valve Periods
Status
Recruiting
People taking part
55 people, planned
Started
27 Jan 2026
Expected to end
31 Dec 2026
Type of study
Interventional
Treatments tested
  • Rhaeos Shunt Monitoring System
Record updated
18 March 2026

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 children and adults who already have a shunt from the brain's fluid spaces that drains brain fluid (CSF). They must have no new or worsening signs that the shunt is failing. The trial tests a wireless skin sensor that checks whether fluid flows through the shunt.

Age
Children and adults
Sex
All sexes
Disease stage
Hydrocephalus treated with a shunt from the brain's fluid spaces. The shunt tube must be felt under intact skin where it crosses the collarbone.
Earlier treatment
Must already have a CSF shunt. For the "virtual off" measurement, the valve must be adjustable from outside the body to an "virtual off" setting. People whose valve will be adjusted must have had a valve adjustment that worked before.

Main reasons for not taking part

  • New or worsening signs of possible shunt failure in the prior 7 days
  • More than one drainage tube in the measured area, an open wound or swelling there, or a shunt deeper than 5 mm under the skin
  • Serious skin reactions to silicone-based adhesives in the past
  • Shunt set to block flow (for example a tied-off shunt, or a valve at 300 mm H2O or higher for some groups), or the doctor thinks the shunt is no longer needed
  • Earlier enrolment in this study or a past Rhaeos study with this device, or another study that could affect the data

The registry criteria, word for word

Show all 31 criteriaShow less

Who can take part

  • Inclusion and Exclusion Criteria for Roll-In Subjects Inclusion criteria
  • Existing ventricular CSF shunt with an available "virtual off" setting which can be programmed noninvasively
  • Region of intact skin overlying an unambiguously identifiable palpable chronically indwelling ventricular shunt which crosses the clavicle and is appropriate in size for application of the study device
  • Signed informed consent by subject or a parent or legal guardian, health care agent, or surrogate decision maker (according to local statutes)
  • Subject-reported or documented history of successful valve adjustment(s); Inclusion and Exclusion Criteria for Main Study Subjects
  • Existing ventricular CSF shunt
  • Region of intact skin overlying an unambiguously identifiable palpable chronically indwelling ventricular shunt which crosses the clavicle and is appropriate in size for application of the study device
  • Signed informed consent by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes); Subjects with planned "virtual off" measurement:; -Existing ventricular CSF shunt with an available "virtual off" setting which can be programmed noninvasively; Subjects with planned adjustment to the "virtual off" setting only:; -Subject-reported or documented history of successful valve adjustment(s)

Who cannot take part

  • Subject-reported new or worsening symptoms of a possible shunt malfunction in the prior 7 days
  • Use of the study device would interfere with standard patient care, or emergency surgery that cannot be delayed, or participation in the study will interfere with, or be detrimental to, administration of optimal healthcare to the subject
  • Prior enrollment in this study
  • Subject-reported new or worsening symptoms of a possible shunt malfunction in the prior 7 days
  • Use of the study device would interfere with standard patient care, or emergency surgery that cannot be delayed, or participation in the study will interfere with, or be detrimental to, administration of optimal healthcare to the subject
  • Prior enrollment in this study
  • Previous participation in a Rhaeos clinical study in which the study device (current generation) was used to acquire measurement data; Subjects with planned "valve normal" measurements:
  • Subject-reported or documented history of serious adverse skin reactions to silicone-based adhesives
  • Subject-reported or documented history of serious adverse skin reactions to silicone-based adhesives
  • 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
  • Shunt is difficult to palpate, or the shunt depth at the device measurement location is deeper than 5 mm from the skin surface via ultrasound measurement
  • Shunt valve is set to an opening pressure of >= 300 mm H2O, or the shunt system is otherwise set to substantially prevent shunt flow (e.g. Certas Plus valve programmed to a setting of 8 or a ligated shunt)
  • Investigator judges that the subject is likely to be shunt independent (e.g. does not require a functional shunt for management of hydrocephalus)
  • Subject has more than one intact and presumed functional distal catheter
  • Participation in any other investigational procedural, pharmaceutical, and/or device study that may influence the collection of valid data under this study
  • 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
  • Shunt is difficult to palpate, or the shunt depth at the device measurement location is deeper than 5 mm from the skin surface via ultrasound measurement
  • Participation in any other investigational procedural, pharmaceutical, and/or device study that may influence the collection of valid data under this study
  • Shunt system is set to substantially prevent shunt flow (e.g. ligated shunt)
  • Investigator judges that the subject is likely to be shunt independent (e.g. does not require a functional shunt for management of hydrocephalus)
  • Subject has more than one intact and presumed functional distal catheter

Where in United States

  • OSF HealthCarePeoria, United StatesContact: Anna SomeraTaking people

About the trial

What the trial wants to find out

This study is evaluating a new, noninvasive device designed to detect whether cerebrospinal fluid (CSF) is flowing through a surgically implanted shunt. CSF shunts are commonly used to treat hydrocephalus, but it can be difficult to tell whether a shunt is working properly without invasive testing or imaging that does not directly measure flow.

Read full original descriptionShow less

The study device is a small, wireless sensor placed on the skin over the shunt tubing, typically near the collarbone. It uses gentle, controlled warmth to measure temperature changes that indicate whether fluid is flowing inside the shunt. The device does not break the skin and does not change a participant's medical care.

This study will enroll children and adults who already have a CSF shunt and who do not have new or worsening symptoms of shunt malfunction. All participants will have a measurement taken while their shunt valve is at its usual prescribed setting. Some participants with programmable shunt valves will also have a second measurement taken after their valve is temporarily adjusted to a setting intended to stop or greatly reduce flow ("virtual off"). After this measurement, the valve will be returned to its prescribed setting.

The study device results will not be shown to participants or their medical providers and will not be used to make treatment decisions. The goal of the study is to determine how well the device can distinguish between shunts that are allowing flow and those that are not.

Participants will be monitored for a short period after device use and, if applicable, after any valve adjustment. The main risks of participation are mild skin irritation from the adhesive or temporary symptoms related to valve adjustment. Participants are not expected to receive a direct medical benefit, but the information gained may help improve future diagnosis of shunt function.

The group in the trial

  • CSF Shunt Flow Assessment with Wireless Thermal DeviceOther group

    Participants undergo noninvasive assessment of cerebrospinal fluid (CSF) shunt flow using a wireless thermal flow detection device placed on the skin overlying the shunt tubing. All participants have a measurement performed at their prescribed shunt valve setting. Participants with programmable valves capable of a manufacturer-reported "virtual off" setting may undergo an additional measurement after temporary valve adjustment to reduce or stop CSF flow, followed by return of the valve to the prescribed setting. Device results are encoded and blinded to participants and clinical staff and are not used for clinical decision-making. Participants are monitored for adverse events during and after device use.

    Treatment: Rhaeos Shunt Monitoring System

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
Detection of Flow in Cerebrospinal Fluid Shunts With a Wireless Thermal Flow Detection Device During Open and Closed Shunt Periods
Plain-language title
Wireless skin sensor to detect fluid flow in hydrocephalus shuntsGenerated 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
18 March 2026