Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06402786
Status:
RECRUITING
Last Update Posted:
2024-06-14
First Post:
2024-04-29
Brief Title:
First-in-human Trial of Home Brain Pressure Measured Using Kitea ICP Sensor Placed During Hydrocephalus Shunt Surgery
Sponsor:
University of Auckland New Zealand
Organization:
University of Auckland New Zealand
Study Overview
Official Title:
Wireless HOME Monitoring of Intracranial BRAIN PRESSURE
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HomeICP
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None