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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06402786




Registration number
NCT06402786
Ethics application status
Date submitted
29/04/2024
Date registered
7/05/2024
Date last updated
14/06/2024

Titles & IDs
Public title
First-in-human Trial of Home Brain Pressure Measured Using Kitea ICP Sensor, Placed During Hydrocephalus Shunt Surgery.
Scientific title
Wireless HOME Monitoring of Intracranial (BRAIN) PRESSURE
Secondary ID [1] 0 0
ADHB-10040
Universal Trial Number (UTN)
Trial acronym
HomeICP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hydrocephalus 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Kitea ICP Sensor

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.


Treatment: Devices: Kitea ICP Sensor
Kitea ICP Sensor placed in brain during shunt surgery.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of device related serious adverse events (Safety of the Kitea ICP Sensor) in the 3 months post-surgery
Timepoint [1] 0 0
3 months
Secondary outcome [1] 0 0
Incidence of device related serious adverse events (Safety of the Kitea ICP Sensor) in the 6 months post-surgery
Timepoint [1] 0 0
6 months
Secondary outcome [2] 0 0
Recruitment rate
Timepoint [2] 0 0
Through study completion, an average of 1 year
Secondary outcome [3] 0 0
Data completeness of home ICP recordings using the Kitea ICP system.
Timepoint [3] 0 0
3 months
Secondary outcome [4] 0 0
Participant satisfaction with the requested frequency of making ICP recordings using the Kitea ICP System.
Timepoint [4] 0 0
3 months

Eligibility
Key inclusion criteria
* 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
Minimum age
1 Year
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/05/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2025
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Other
Name
University of Auckland, New Zealand
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Health Research Council, New Zealand
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Government body
Name [2] 0 0
Auckland City Hospital
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Kitea Health Ltd
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT06402786
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sarah-Jane Guild, PhD
Address 0 0
The University of Auckland
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Sarah-Jane Guild, PhD
Address 0 0
Country 0 0
Phone 0 0
+64212969030
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06402786