Suspended

HomeICPKitea Sensor for Home Monitoring of Brain Pressure in Hydrocephalus Patients

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Study Aim

This study aims to evaluate the safety and tolerability of the Kitea ICP Sensor in patients with hydrocephalus, by monitoring the incidence of device-related serious adverse events within the 3 months following surgery.

What is being tested

Kitea ICP Sensor

Device
Who is being recruted

Brain Diseases+1

+ Central Nervous System Diseases

+ Hydrocephalus

Over 1 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: May 2024
See protocol details

Summary

Principal SponsorUniversity of Auckland, New Zealand
Last updated: February 14, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 27, 2024

Actual date on which the first participant was enrolled.

This study is focused on helping people with hydrocephalus, a condition where excess fluid accumulates in the brain, causing increased pressure. Many of these patients have shunts placed to help drain the fluid, but these shunts can sometimes fail, leading to repeated hospital visits. The goal is to see if monitoring brain pressure at home using a special device called the Kitea Sensor can reduce the need for hospitalizations. By allowing patients to keep track of their brain pressure, it might be possible to detect problems earlier and manage them more effectively. Participants in this study include both adults and children who need a shunt placed or revised. During their surgery, the Kitea Sensor is placed in the brain near the shunt. For three months after the surgery, participants will use the Kitea ICP System at home to check their brain pressure. This involves taking regular readings to monitor any changes in pressure. The study evaluates if this home monitoring can help manage hydrocephalus better and potentially reduce the number of hospital visits needed for shunt issues. Beyond the use of the Kitea Sensor, all other medical care will follow standard procedures.

Official TitleWireless HOME Monitoring of Intracranial (BRAIN) PRESSURE
NCT06402786
Principal SponsorUniversity of Auckland, New Zealand
Last updated: February 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

21 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 1 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Brain DiseasesCentral Nervous System DiseasesHydrocephalusNervous System Diseases

Criteria

2 inclusion criteria required to participate
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

9 exclusion criteria prevent from participating
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

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Auckland City Hospital

Auckland, New ZealandOpen Auckland City Hospital in Google Maps
SuspendedOne Study Center