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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT06402786
Registration number
NCT06402786
Ethics application status
Date submitted
29/04/2024
Date registered
7/05/2024
Date last updated
7/05/2024
Titles & IDs
Public title
First-in-human Trial of Home Brain Pressure Measured Using Kitea ICP Sensor, Placed During Hydrocephalus Shunt Surgery.
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Scientific title
Wireless HOME Monitoring of Intracranial (BRAIN) PRESSURE
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Secondary ID [1]
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ADHB-10040
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Universal Trial Number (UTN)
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Trial acronym
HomeICP
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hydrocephalus
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Condition category
Condition code
Neurological
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Other neurological disorders
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Incidence of device related serious adverse events (Safety of the Kitea ICP Sensor) in the 3 months post-surgery
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Assessment method [1]
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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.
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Timepoint [1]
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3 months
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Secondary outcome [1]
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Incidence of device related serious adverse events (Safety of the Kitea ICP Sensor) in the 6 months post-surgery
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Assessment method [1]
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The secondary safety end point for this study is the proportion of recruited participants who have no safety or tolerability issues in the 6 months post-surgery as assessed by a lack of serious adverse events attributable to the Kitea ICP System or participants requesting device removal.
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Timepoint [1]
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6 months
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Secondary outcome [2]
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Recruitment rate
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Assessment method [2]
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Proportion of all eligible participants who are enrolled over the study duration.
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Timepoint [2]
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Through study completion, an average of 1 year
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Secondary outcome [3]
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Data completeness of home ICP recordings using the Kitea ICP system.
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Assessment method [3]
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Wireless home ICP monitoring will be considered successful if 90% of the attempted ICP measures are able to be obtained.
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Timepoint [3]
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3 months
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Secondary outcome [4]
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Participant satisfaction with the requested frequency of making ICP recordings using the Kitea ICP System.
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Assessment method [4]
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As part of the protocol participants will be asked to make daily ICP measurements using the Kieta ICP system for the first 2 weeks after surgery and then make measurements at least every second day for the remainder of the 3 months. A participant survey at 3 months will collect participant feedback on the perceived burden of making those measurements.
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Timepoint [4]
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3 months
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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
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Minimum age
1
Year
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
1/05/2024
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2025
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Actual
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Sample size
Target
20
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Auckland
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of Auckland, New Zealand
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Health Research Council, New Zealand
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Auckland City Hospital
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Address [2]
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Country [2]
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Other collaborator category [3]
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Other
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Name [3]
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Kitea Health Ltd
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Address [3]
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Country [3]
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT06402786
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Sarah-Jane Guild, PhD
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Address
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The University of Auckland
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Sarah-Jane Guild, PhD
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Address
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Country
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Phone
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+64212969030
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT06402786
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