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

NCT06402786 | Active Not Recruiting DMC

• 1 other identifier: ADHB-10040
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Hydrocephalus

Keywords

Intracranial Pressure

Outcome Measures

Primary Outcomes (1)

• Incidence of device related serious adverse events (Safety of the Kitea ICP Sensor) in the 3 months post-surgery

  The primary end point for this study is the proportion of recruited participants who have no safety or tolerability issues in the 3 months post-surgery as assessed by a lack of serious adverse events attributable to the Kitea ICP System or participants requesting device removal.

  3 months

Secondary Outcomes (4)

• Incidence of device related serious adverse events (Safety of the Kitea ICP Sensor) in the 6 months post-surgery

  6 months

• Recruitment rate

  Through study completion, an average of 1 year

• Data completeness of home ICP recordings using the Kitea ICP system.

  3 months

• Participant satisfaction with the requested frequency of making ICP recordings using the Kitea ICP System.

  3 months

Other Outcomes (1)

• Number of potentially shunt related clinical events where the Kitea ICP measurements would have provided clinically appropriate ICP values.

  3 months

Study Arms (1)

Kitea ICP Sensor

EXPERIMENTAL

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.

Device: Kitea ICP Sensor

Interventions

Kitea ICP Sensor DEVICE

Kitea ICP Sensor placed in brain during shunt surgery.

Kitea ICP Sensor

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Auckland, New Zealand: lead
• Health Research Council, New Zealand: collaborator
• Auckland City Hospital: collaborator
• Kitea Health Ltd: collaborator

Study Sites (1)

Auckland City Hospital

Auckland, New Zealand

Location

MeSH Terms

Conditions

Hydrocephalus

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Sarah-Jane Guild, PhD

  The University of Auckland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 29, 2024
• First Posted: May 7, 2024
• Study Start: May 27, 2024
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (1)