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

University of Auckland, New Zealand

Status: Enrolling

Conditions: Hydrocephalus

Treatments: Device: Kitea ICP Sensor

Study type: Interventional

Funder types: Other

Identifiers

NCT06402786

ADHB-10040

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 1+ year old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Kitea ICP Sensor

Experimental group

Description:

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.

Treatment:

Device: Kitea ICP Sensor