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.

NCT Number	NCT06402786
Lead Sponsor	University of Auckland, New Zealand Collaborators: Health Research Council, New Zealand, Auckland City Hospital, Kitea Health Ltd
Conditions	Hydrocephalus
Enrollment	21 participants
Start Date	2024-05-27
Primary Completion	2026-04 (estimated)
Study Completion	2026-04 (estimated)
Updated on ClinicalTrials.gov	2026-02-13