HydrocephalusHomeICPNCT06402786
First-in-human Trial of Home Brain Pressure Measured Using Kitea ICP Sensor, Placed During Hydrocephalus Shunt Surgery.
A study testing Kitea ICP Sensor in people with Hydrocephalus, run by University of Auckland, New Zealand at 1 site in New Zealand.
Trial summary
Patients with hydrocephalus have an abnormal build-up of fluid around the brain and need a tube surgically implanted to drain that fluid. Patients and their caregivers live with the constant fear that the tube will block. Warning symptoms include irritability, headaches and vomiting. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Hydrocephalus
- What is being tested?
- Kitea ICP Sensor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteNew Zealand
- Study dates
- 27 May 2024to Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Wireless HOME Monitoring of Intracranial (BRAIN) PRESSURE
Patients with hydrocephalus have an abnormal build-up of fluid around the brain and need a tube surgically implanted to drain that fluid. Patients and their caregivers live with the constant fear that the tube will block. Warning symptoms include irritability, headaches and vomiting. Unfortunately, there is no way of telling when fluid build-up is causing a rise in brain pressure and potentially impeding blood flow to the brain (life threatening) except for a brain scan in hospital and possibly hospitalisation.
The investigators want to improve the lives of patients with hydrocephalus. They have developed a tool for parents and caregivers to monitor the pressure in the brain remotely via a sensor placed alongside the drainage tube. The device has been shown to be safe and to give reliable brain pressure readings using a large animal model (sheep). This study is a first-in-human safety study to show it is safe for patient use.
Read the detailed description
Participants with hydrocephalus who are at risk of repeated bouts of hospitalisation associated with shunt failures and therefore likely to benefit from being able to monitor intracranial pressure will be recruited. 10 adult (>16 years) and 10 children (1-15 years) participants will be recruited in a staggered fashion to allow appropriate evaluation of outcomes. Participants will be recruited when they present to hospital requiring a shunt placement (or revision). At the same time as this surgery, the Kitea Sensor will be placed in the brain near the shunt. Participants will be asked to make measurements of their brain pressure at home using the Kitea ICP System for the next 3 months. Aside from the placement of the Kitea Sensor and home measurements of ICP using the Kitea ICP system, all clinical interventions will be standard of care.
- Conditions
- Hydrocephalus
- Being tested
- Kitea ICP Sensor
- Keywords
- Intracranial Pressure
- Medical subject headings
- Hydrocephalus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kitea ICP SensorDevice
Kitea ICP Sensor placed in brain during shunt surgery.
| Study group | Role | What they receive |
|---|---|---|
| Kitea ICP Sensor | Experimental | At the same time as this surgery, the Kitea Sensor will be placed in the brain near the shunt. Participants will be asked to make measurements of their brain pressure at home using the Kitea ICP System for the next 3 months. Aside from the placement of the Kitea Sensor and home measurements of ICP using the Kitea ICP system, all clinical interventions will be standard of care. Receives: Device: Kitea ICP Sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of device related serious adverse events (Safety of the Kitea ICP Sensor) in the 3 months post-surgery
The primary end point for this study is the proportion of recruited participants who have no safety or tolerability issues in the 3 months post-surgery as assessed by a lack of serious adverse events attributable to the Kitea ICP System or participants requesting device removal.
Measured: 3 months
Secondary outcomes (4)
Incidence of device related serious adverse events (Safety of the Kitea ICP Sensor) in the 6 months post-surgery
The secondary safety end point for this study is the proportion of recruited participants who have no safety or tolerability issues in the 6 months post-surgery as assessed by a lack of serious adverse events attributable to the Kitea ICP System or participants requesting device removal.
Measured: 6 months
Recruitment rate
Proportion of all eligible participants who are enrolled over the study duration.
Measured: Through study completion, an average of 1 year
Data completeness of home ICP recordings using the Kitea ICP system.
Wireless home ICP monitoring will be considered successful if 90% of the attempted ICP measures are able to be obtained.
Measured: 3 months
Participant satisfaction with the requested frequency of making ICP recordings using the Kitea ICP System.
As part of the protocol participants will be asked to make daily ICP measurements using the Kieta ICP system for the first 2 weeks after surgery and then make measurements at least every second day for the remainder of the 3 months. A participant survey at 3 months will collect participant feedback on the perceived burden of making those measurements.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2024
- Study start27 May 2024
- Primary completionApr 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HydrocephalusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Auckland, New Zealand
- Sponsor type
- University, hospital or other
- Collaborators
- Health Research Council, New Zealand, Auckland City Hospital, Kitea Health Ltd
- Responsible party
- Principal investigator, Sarah-Jane Guild, University of Auckland, New Zealand
- Investigators
- Sarah-Jane Guild, PhD, Principal investigator, The University of Auckland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06402786
- Sponsor's protocol ID
- ADHB-10040
- Acronym
- HomeICP
- Status last verified
- Feb 2026
- First submitted
- 29 Apr 2024
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wireless HOME Monitoring of Intracranial (BRAIN) PRESSURE
- ClinicalTrials.gov ID
- NCT06402786
- Acronym / sponsor ID
- HomeICP / ADHB-10040
- Conditions
- Hydrocephalus
- Keywords
- Intracranial Pressure
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of Auckland, New ZealandUniversity, hospital or other
- Collaborators
- Health Research Council, New Zealand, Auckland City Hospital, Kitea Health Ltd
- Study start
- 27 May 2024 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 7 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with hydrocephalus have an abnormal build-up of fluid around the brain and need a tube surgically implanted to drain that fluid. Patients and their caregivers live with the constant fear that the tube will block. Warning symptoms include irritability, headaches and vomiting. Unfortunately, there is no way of telling when fluid build-up is causing a rise in brain pressure and potentially impeding blood flow to the brain (life threatening) except for a brain scan in hospital and possibly hospitalisation.
The investigators want to improve the lives of patients with hydrocephalus. They have developed a tool for parents and caregivers to monitor the pressure in the brain remotely via a sensor placed alongside the drainage tube. The device has been shown to be safe and to give reliable brain pressure readings using a large animal model (sheep). This study is a first-in-human safety study to show it is safe for patient use.
Detailed description
Participants with hydrocephalus who are at risk of repeated bouts of hospitalisation associated with shunt failures and therefore likely to benefit from being able to monitor intracranial pressure will be recruited. 10 adult (>16 years) and 10 children (1-15 years) participants will be recruited in a staggered fashion to allow appropriate evaluation of outcomes. Participants will be recruited when they present to hospital requiring a shunt placement (or revision). At the same time as this surgery, the Kitea Sensor will be placed in the brain near the shunt. Participants will be asked to make measurements of their brain pressure at home using the Kitea ICP System for the next 3 months. Aside from the placement of the Kitea Sensor and home measurements of ICP using the Kitea ICP system, all clinical interventions will be standard of care.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Kitea ICP Sensor | Experimental | Device: Kitea ICP SensorAt the same time as this surgery, the Kitea Sensor will be placed in the brain near the shunt. Participants will be asked to make measurements of their brain pressure at home using the Kitea ICP System for the next 3 months. Aside from the placement of the Kitea Sensor and home measurements of ICP using the Kitea ICP system, all clinical interventions will be standard of care. |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kitea ICP SensorKitea ICP Sensor placed in brain during shunt surgery. | Device | Kitea ICP Sensor |
Primary outcome
Incidence of device related serious adverse events (Safety of the Kitea ICP Sensor) in the 3 months post-surgery
Time frame: 3 months
The primary end point for this study is the proportion of recruited participants who have no safety or tolerability issues in the 3 months post-surgery as assessed by a lack of serious adverse events attributable to the Kitea ICP System or participants requesting device removal.
4 secondary outcomes
Incidence of device related serious adverse events (Safety of the Kitea ICP Sensor) in the 6 months post-surgery
Time frame: 6 months
Recruitment rate
Time frame: Through study completion, an average of 1 year
Data completeness of home ICP recordings using the Kitea ICP system.
Time frame: 3 months
Participant satisfaction with the requested frequency of making ICP recordings using the Kitea ICP System.
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah-Jane Guild, PhD principal investigator
The University of Auckland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kitea ICP Sensor in people with Hydrocephalus, run by University of Auckland, New Zealand at 1 site in New Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of device related serious adverse events (Safety of the Kitea ICP Sensor) in the 3 months post-surgery (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.