First-in-human Trial of Home Brain Pressure Measured Using Kitea ICP Sensor, Placed During Hydrocephalus Shunt Surgery. - Trial NCT06402786
Access comprehensive clinical trial information for NCT06402786 through Pure Global AI's free database. This phase not specified trial is sponsored by University of Auckland, New Zealand and is currently Not yet recruiting. The study focuses on Hydrocephalus. Target enrollment is 20 participants.
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Study Focus
Sponsor & Location
University of Auckland, New Zealand
Timeline & Enrollment
N/A
May 01, 2024
Dec 01, 2025
Primary Outcome
Incidence of device related serious adverse events (Safety of the Kitea ICP Sensor) in the 3 months post-surgery
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06402786
Device Trial