Wireless HOME Monitoring of Intracranial (BRAIN) PRESSURE

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
New Zealand
Auckland City Hospital
RECRUITING
Auckland
Contact Information
Primary
Sarah-Jane Guild, PhD
s.guild@auckland.ac.nz
+64212969030
Backup
Davina J McAllister
davinams@adhb.govt.nz
+6493757095
Time Frame
Start Date: 2024-05-27
Estimated Completion Date: 2025-12
Participants
Target number of participants: 20
Treatments
Experimental: Kitea ICP Sensor
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.
Related Therapeutic Areas
Sponsors
Leads: University of Auckland, New Zealand
Collaborators: Health Research Council, New Zealand, Auckland City Hospital, Kitea Health Ltd

This content was sourced from clinicaltrials.gov