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Active, Not Recruiting

NCT Number: NCT06402786

First-in-human Trial of Home Brain Pressure Measured Using Kitea ICP Sensor, Placed During Hydrocephalus Shunt Surgery.

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Hydrocephalus Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

1 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Auckland City Hospital

Auckland, New Zealand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Kitea ICP Sensor

Device

Kitea ICP Sensor placed in brain during shunt surgery.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Incidence of device related serious adverse events (Safety of the Kitea ICP Sensor) in the 6 months post-surgery

    Time frame: 6 months

    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.

  2. Recruitment rate

    Time frame: Through study completion, an average of 1 year

    Proportion of all eligible participants who are enrolled over the study duration.

  3. Data completeness of home ICP recordings using the Kitea ICP system.

    Time frame: 3 months

    Wireless home ICP monitoring will be considered successful if 90% of the attempted ICP measures are able to be obtained.

  4. Participant satisfaction with the requested frequency of making ICP recordings using the Kitea ICP System.

    Time frame: 3 months

    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.

Other outcomes

  1. Number of potentially shunt related clinical events where the Kitea ICP measurements would have provided clinically appropriate ICP values.

    Time frame: 3 months

    The Kitea ICP system will not change shunt performance and the presence of the Kitea Sensor will not stop a shunt failing but it is intended that the ICP values recorded will inform decision making around the whether a shunt is failing or not. In this safety and tolerability study, the ICP values will not be used in clinical decision making. However, as an indication of potential future benefit, any clinical event (defined as the participant seeking clinical care) will be categorised along with the Kitea ICP value associated with that event. This will be presented as a confusion matrix including false and true positives (i.e. shunt failures) and false and true negatives (i.e. false alarms).

Sponsors and collaborators

Lead sponsor

University of Auckland, New Zealand

Other

Collaborators

  • Auckland City Hospital
  • Health Research Council, New Zealand
  • Kitea Health Ltd

Registry information

Official study title

Wireless HOME Monitoring of Intracranial (BRAIN) PRESSURE

Acronym: HomeICP

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 7, 2024
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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