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New wireless sensor could let hydrocephalus patients monitor brain pressure at home

NCT ID NCT06402786

Disease control Sponsor: University of Auckland, New Zealand Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new wireless sensor placed in the brain during shunt surgery for hydrocephalus. The sensor aims to let patients and caregivers monitor brain pressure from home, reducing the need for hospital scans and easing fear of shunt blockages. It is a first-in-human safety trial with 21 participants, focusing on whether the device is safe over 3 to 6 months.

What this could mean

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

Active substance
Kitea ICP Sensor (a wireless device implanted in the brain during shunt surgery)
What this could lead to
If successful, this could give patients and caregivers a way to monitor brain pressure at home, potentially catching dangerous blockages early and reducing emergency hospital visits.
What could go wrong
This is a very early, small safety study with only 21 participants, so it may not prove the device works reliably. There are also risks of infection or device malfunction from the implanted sensor.

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

21 people

The number who actually took part.

Started

May 2024

Expected to finish

Apr 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

1 year 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: * Participants with a condition requiring cerebral spinal fluid shunting who are undergoing initial shunt placement or shunt revision surgery. * Adults: Age \> 16 years; Children: Age \>1 and \<15 Exclusion Criteria: * Adults: Unable to give informed consent * Paediatric: Failure to obtain assent in a cognitively competent child along with parental consent or parent unable to consent. * Cortical mantle \< 20 mm * Neurologic or other condition that would prevent compliance with protocol * Terminal illness with expected survival \< 1 year * Unable to participate in follow-up for 3 months (e.g., travelling overseas for an extended period) * Underlying medical condition that would make the participant more prone to surgical infections * Other active implanted medical devices e.g. pacemaker, cochlear implant, implantable cardioverter defibrillator, deep brain stimulation devices * Participants with conditions likely to require radiation therapy

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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

Contacts and locations

Locations

  • Auckland City Hospital

    Auckland, New Zealand

More trials for these conditions

Other studies related to the condition(s) this trial covers.