Sticker on the skin could replace scans for shunt checks
NCT ID NCT07679035
First seen Jul 01, 2026 · Last updated Jul 02, 2026 · Updated 1 time
Summary
This study tests a new wireless, noninvasive device called the Rhaeos Shunt Monitoring System (RSMS) that sticks to the skin to detect fluid flow in brain shunts used for hydrocephalus. About 85 children and adults with working shunts will have their shunt flow measured with both the RSMS and an existing FDA-cleared device. The goal is to see if the new device can accurately tell when a shunt is blocked or flowing normally, potentially offering a simpler way to check shunt function without imaging or invasive procedures.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Rhaeos Shunt Monitoring System (RSMS)
- What this could lead to
- If successful, this could lead to a simple, noninvasive tool for doctors to quickly check if a shunt is working, reducing the need for scans or invasive tests.
- What could go wrong
- This is an early-stage study with only 85 participants, and the device is not yet proven to be accurate enough for clinical use. It may not work as well as hoped.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 85 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 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). Exclusion Criteria: 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. Subject-reported or documented history of serious adverse skin reactions to silicone-based adhesives. 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. Participation in another investigational procedural, pharmaceutical, or device study that may affect data collected in this study. Previous participation in a Rhaeos clinical study using the current-generation RH05-B1 study device. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Rhaeos, Imc
Chicago, Illinois, 60642, United States
Contact Email: •••••@•••••
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Radiation-Free brain imaging for kids? ultrasound may offer a safer path
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- Wearable device could monitor brain shunt function from home
- Keyhole brain surgery could spare children from shunt complications
- New MRI method could spot reversible dementia more accurately