Early access
Sign in
Not yet taking people in United StatesNo phase

Comparing skin sensors that check fluid flow in hydrocephalus shunts

Compares skin sensors checking shunt flow in people with hydrocephalus.

Key facts

Who runs it
Rhaeos, Inc.
Where
Chicago, United StatesSee the site
Trial code
Registry title
Study of Shunt Flow Under Different Valve Settings Using a Wireless Sensor
Status
Not yet recruiting
People taking part
85 people, planned
Started
30 Jun 2026
Expected to end
31 Dec 2026
Type of study
Interventional
Treatments tested
  • Rhaeos Shunt Monitoring System (RSMS)
  • ShuntCheck III
Record updated
1 July 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 with hydrocephalus who already have a working ventricular CSF shunt (a tube that drains extra fluid from the brain). It tests a wireless skin sensor that checks shunt flow.

Age
Children and adults
Sex
All sexes
Disease stage
Hydrocephalus with an existing, long-standing ventricular shunt. The shunt must be easy to feel under intact skin where it crosses the collarbone. No new or worsening signs of shunt problems in the last 7 days.
Earlier treatment
Must already have a ventricular CSF shunt. For the "virtual off" part: a programmable valve with a "virtual off" setting, and a past successful valve adjustment.

Main reasons for not taking part

  • More than one shunt tube in the measurement area
  • Open wound or swelling where the device goes
  • Shunt hard to feel or deeper than 5 mm under the skin on ultrasound
  • Serious past skin reaction to silicone-based adhesives
  • Past participation in a Rhaeos study with the RH05-B1 device, or another study that may affect results

The registry criteria, word for word

Show all 17 criteriaShow less

Who can take part

  • Existing ventricular cerebrospinal fluid (CSF) shunt. Region of intact skin overlying an unambiguously identifiable, palpable, chronically indwelling ventricular shunt crossing the clavicle and appropriate in size for application of the study device
  • Written informed consent provided by the participant or, when applicable, by a parent, legal guardian, health care agent, or surrogate decision maker according to local regulations
  • For participants with planned "virtual off" measurements:
  • Existing ventricular CSF shunt with a programmable valve that has an available manufacturer-reported "virtual off" setting and can be programmed noninvasively
  • For participants whose valve will be adjusted to the "virtual off" setting during the study:
  • Subject-reported or documented history of successful shunt valve adjustment(s)

Who cannot take part

  • New or worsening symptoms suggestive of shunt malfunction within the previous 7 days
  • Use of the study device would interfere with standard patient care, emergency surgery cannot be delayed, or study participation would interfere with optimal medical care
  • Previous participation in a Rhaeos clinical study using the current-generation RH05-B1 study device
  • 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 open wound or edema in the study device measurement region that would interfere with device placement
  • Shunt difficult to palpate or shunt depth greater than 5 mm from the skin surface at the measurement location as determined by ultrasound
  • Participation in another investigational procedural, pharmaceutical, or device study that may affect data collected in this study
  • For participants with planned "valve normal" measurements only:
  • Investigator judges the participant is likely to be shunt independent (e.g., does not require a functional shunt for management of hydrocephalus)
  • This format follows ClinicalTrials.gov conventions by separating general criteria from those that apply only to specific participant subgroups

Where in United States

  • Rhaeos, ImcChicago, United StatesContact: Anna L SomeraNot yet recruiting

About the trial

What the trial wants to find out

Hydrocephalus is commonly treated with a cerebrospinal fluid (CSF) shunt, a device that drains excess fluid from the brain. However, shunts can stop working over time, and determining whether fluid is flowing through a shunt can be difficult. Current diagnostic methods may require imaging studies or invasive procedures, which can be time-consuming, costly, or uncomfortable for patients.

Read full original descriptionShow less

The purpose of this study is to evaluate the performance of the Rhaeos Shunt Monitoring System (RSMS), an investigational wireless, noninvasive device designed to detect flow in implanted CSF shunts. The study will compare RSMS directly with ShuntCheck III, an FDA-cleared noninvasive device that is also used to assess CSF shunt flow. Both devices are placed on the skin over the shunt and use thermal sensing technology to evaluate whether fluid is flowing through the shunt.

Approximately 85 pediatric and adult participants with an existing ventricular CSF shunt will be enrolled. Participants must have a functioning shunt and no recent symptoms suggesting shunt malfunction. Some participants with programmable shunt valves will have their valve temporarily adjusted to a manufacturer-provided "virtual off" setting, which is intended to substantially restrict shunt flow. These participants may also undergo measurements at their normal valve setting. Other participants will only undergo measurements at their normal valve setting.

During the study visit, participants will undergo shunt flow assessments with both RSMS and ShuntCheck III. The order in which the devices are used will be randomized. Device measurements are collected while participants are seated upright, and participants and their treating clinicians will remain blinded to the measurement results. The study devices will not be used to make treatment decisions, and participation will not alter standard medical care. Adverse events associated with device use or valve adjustments will be monitored and recorded.

The primary goal of the study is to compare the ability of RSMS and ShuntCheck III to correctly identify shunts with flow-permissive ("valve normal") and restricted-flow ("virtual off") settings. Results from this study may help support the future development of a noninvasive tool to aid neurosurgeons in assessing CSF shunt flow. Participants are not expected to receive a direct medical benefit from taking part in the study.

The group in the trial

  • Participants Undergoing Paired CSF Shunt Flow AssessmentOther group

    Participants undergo paired, noninvasive assessment of cerebrospinal fluid (CSF) shunt flow using both the investigational Rhaeos® Shunt Monitoring System (RSMS) and the FDA-cleared predicate device, ShuntCheck III. The order of device use is randomized for each participant. All participants are evaluated at their prescribed flow-permissive ("valve normal") shunt setting. Participants with programmable shunt valves that can be adjusted to a manufacturer-reported "virtual off" setting also undergo measurements after temporary adjustment to the "virtual off" setting, followed by return of the valve to the prescribed setting. Device results are blinded to participants and treating clinicians and are not used for clinical decision-making. Adverse events are monitored throughout study participation.

    Treatment: Rhaeos Shunt Monitoring System (RSMS) and ShuntCheck III

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
A Prospective Study Comparing CSF Shunt Flow Between "Virtual Off" and "Flow-Permissive" Shunt Valve Settings Using a Wireless, Noninvasive Shunt Flow Sensor
Plain-language title
Comparing skin sensors that check 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
1 July 2026