Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06368648
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-16
First Post:
2024-04-11
Brief Title:
CoMind Early Feasibility Study
Sponsor:
CoMind Technologies Limited
Organization:
CoMind Technologies Limited
Study Overview
Official Title:
An Early Feasibility Study for the Development of a Model to Non-Invasively Estimate Intracranial Pressure ICP and New Metrics of Cerebral Autoregulation CAR Using the CoMind One EFS Device
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CoMind EFS
Brief Summary:
The purpose of this research which has been determined as non-significant risk by the central IRB overseeing the study is to obtain information to help further develop a machine a medical device to measure the pressure around the brain from the outside this pressure is called intracranial pressure or ICP Monitoring and managing ICP is an important part of care for patients with conditions such as Traumatic Brain Injury TBI However the current way of measuring ICP requires surgery to drill a hole into the skull and therefore can introduce additional risks such as infections and pain
Recent research has shown it may be possible to measure ICP without needing surgery This technology is in development but large amounts of data is required to build these new devices
Through collecting a large database of information from patients who have both the routine surgical device and the research device applied to their head the research team will work to develop and test an effective and potentially safer way of monitoring patient ICP
Recent research has shown it may be possible to measure ICP without needing surgery This technology is in development but large amounts of data is required to build these new devices
Through collecting a large database of information from patients who have both the routine surgical device and the research device applied to their head the research team will work to develop and test an effective and potentially safer way of monitoring patient ICP
Detailed Description:
A prospective observational study determined as non-significant risk by the Central IRB to assess and improve performance of a non-invasive ICP estimation system The development of non-invasive systems is intended to replace the need for invasive ICP monitors Participants serve as their own controls with concurrent synchronous measurements of ICP measured invasively as per standard clinical practice Arterial Blood Pressure ABP- measured invasively as per standard clinical practice and measurements of a novel non- invasive cerebral blood-flow index CBFi from the CoMind One EFS device These signals will be recorded simultaneously The ABP and CBFi will serve as inputs to a model which outputs a non-invasive estimate of ICP and the invasive ICP signal will be used to supervise and evaluate the performance of the non-invasive ICP estimation model A large volume of data shall be collected for the purposes of training and testing the non-invasive ICP model The Sponsor will report limits of agreement LOA between data-driven estimates of ICP and the invasively measured signal In addition this study will compare metrics built on non-invasive estimation of ICP or CBFi that indicate the state of CAR and the limits of Autoregulation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None