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Wearable device could monitor brain shunt function from home

NCT ID NCT07050628

Knowledge-focused Sponsor: Rhaeos, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 21, 2026 · Last updated Aug 26, 2026 · Updated 4 times

Summary

This study tests a wearable device that measures fluid flow in cerebrospinal fluid shunts, which are used to treat hydrocephalus. Participants wear the device at home during normal activities and sleep to see if it can safely and reliably track shunt function. The goal is to develop a non-invasive way to monitor shunts without frequent clinic visits.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
wireless thermal anisotropy measurement device
What this could lead to
If successful, this device could allow people with hydrocephalus to monitor their shunt function at home, potentially catching problems early without frequent hospital visits.
What could go wrong
This is a small, early-stage study focused on device safety and feasibility, not on proving clinical benefits. The device may not be accurate enough for widespread use.

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 28 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Jun 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

2 years and older

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: 1. Existing ventricular CSF shunt 2. (Cohort A) A history of stable ventricular size, no shunt revision in the previous 2 years, and no current symptoms of shunt failure 3. (Cohort B) A shunt revision in the previous 7 days and the investigator judges that the patient will likely be discharged within 4 days of the enrollment date 4. 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 5. Signed informed consent by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes) 6. Subject is at least 5 years old but \< 22 years old Exclusion Criteria: 1. Shunt is not palpable or depth of shunt where the device will be placed is greater than 4 mm per ultrasound evaluation 2. Presence of an interfering open wound or edema in the study device measurement region 3. Subject-reported history of serious adverse skin reactions to silicone-based adhesives 4. Investigator judges that the subject is likely to be lost to follow-up due to unavailability or clinical outcome being unobtainable 5. Investigator judges that the subject is unlikely to successfully take reliable measurements at home 6. Investigator judges that the subject/subject's caretaker would not be able to successfully place the device without assistance 7. 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 8. Prior enrollment in this study 9. Participation in any other investigational procedural, pharmaceutical, and/or device study that may influence the collection of valid data under this study

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Conditions

The condition(s) this trial relates to.

hydrocephalus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hydrocephalus

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

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

  2. The places running it

    2 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. 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

Locations

  • Rhaeos Inc.

    RECRUITING

    Chicago, Illinois, 60642, United States

    Contact Email: •••••@•••••

  • Virginia Commonwealth University Medical Center

    RECRUITING

    Richmond, Virginia, 23298, United States

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