Clinical trial NCT06402786: First-in-human Trial of Home Brain Pressure Measured Using Kitea ICP Sensor, Placed During Hydrocephalus Shunt Surgery.
Official title: Wireless HOME Monitoring of Intracranial (BRAIN) PRESSURE
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hydrocephalus
Keywords: Intracranial Pressure
Lead sponsor: University of Auckland, New Zealand
Sponsor class: OTHER
Collaborators: name: Health Research Council, New Zealand
name: Auckland City Hospital
name: Kitea Health Ltd
First posted: 2024-05-07
Enrollment: 20
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of device related serious adverse events (Safety of the Kitea ICP Sensor) in the 3 months post-surgery
timeFrame: 3 months
Secondary outcomes:
measure: Incidence of device related serious adverse events (Safety of the Kitea ICP Sensor) in the 6 months post-surgery
timeFrame: 6 months
measure: Recruitment rate
timeFrame: Through study completion, an average of 1 year
measure: Data completeness of home ICP recordings using the Kitea ICP system.
timeFrame: 3 months
measure: Participant satisfaction with the requested frequency of making ICP recordings using the Kitea ICP System.
timeFrame: 3 months
Other outcomes:
measure: Number of potentially shunt related clinical events where the Kitea ICP measurements would have provided clinically appropriate ICP values.
timeFrame: 3 months
Locations:
city: Auckland
country: New Zealand
facility: Auckland City Hospital
Study officials:
affiliation: The University of Auckland
name: Sarah-Jane Guild, PhD
role: PRINCIPAL_INVESTIGATOR
References: