Wireless skin sensor aims to detect silent shunt failures
NCT ID NCT07815314
First seen Sep 11, 2026 · Last updated Sep 11, 2026
Summary
Hydrocephalus is often treated with a shunt that drains excess fluid from the brain, but shunts can stop working and checking flow usually requires imaging or invasive tests. This study compares two noninvasive thermal sensors placed on the skin over the shunt: the investigational Rhaeos Shunt Monitoring System and the FDA-cleared ShuntCheck III. About 85 children and adults with an existing ventricular shunt take part. Some participants with programmable valves have their valve temporarily set to a restricted-flow setting so researchers can compare sensor readings when flow is blocked versus normal. Device results are blinded and do not guide treatment.
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, a wireless noninvasive thermal sensor placed on the skin over a cerebrospinal fluid shunt
- What this could lead to
- If it works, neurosurgeons could one day check whether a hydrocephalus shunt is flowing without imaging or invasive procedures.
- What could go wrong
- The study is small and does not use device results to guide care, so it may not show a clear advantage over the existing ShuntCheck III. Temporary valve adjustments carry some risk of discomfort or shunt malfunction.
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
-
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
-
About 85 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Sep 2026
An estimate. Start dates often move.
- Expected to finish
-
Jan 2027
An estimate. End dates often move.
- Lead sponsor
-
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
-
Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
-
Anyone
- Healthy volunteers
-
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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Hydrocephalus are added.
By submitting, you agree to our Terms of use
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.
-
The study's own enquiry address
This study publishes an address for enquiries. See it below .
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
Enter your email to view the contact information for this study.
By submitting, you agree to our Terms of use
Study contacts
-
Contact
Email: •••••@•••••
Locations
-
Rhaeos, Inc
Chicago, Illinois, 60642, United States
Contact Email: •••••@•••••
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Radiation-Free brain imaging for kids? ultrasound may offer a safer path
- Can a Brain-Stiffness scan spot a treatable form of dementia?
- Wearable device could monitor brain shunt function from home
- Keyhole brain surgery could spare children from shunt complications
- Sticker on the skin could replace scans for shunt checks
- New MRI method could spot reversible dementia more accurately