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Wireless skin sensor aims to detect silent shunt failures

NCT ID NCT07815314

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

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  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

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    Open the record ↗

  4. A doctor treating you

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Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Rhaeos, Inc

    Chicago, Illinois, 60642, United States

    Contact Email: •••••@•••••

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