Ignite Creation Date:
2024-05-06 @ 8:08 PM
Last Modification Date:
2025-12-17 @ 3:21 AM
Study NCT ID:
NCT06267131
Status:
None
Last Update Posted:
2024-02-20 00:00:00
First Post:
2023-11-08 00:00:00
Brief Title:
Transcutaneous Pulse Oximetry Brain Monitoring Study (US)
Sponsor:
Cyban Pty Ltd
Organization:
Cyban Pty Ltd
Study Overview
Official Title:
Transcutaneous Pulse Oximetry Brain Monitoring Study (US): T-POT Study
Status:
None
Status Verified Date:
2024-02
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:
T-POT US
Brief Summary:
The device is a non-invasive brain pulse oximeter. It uses red and near-infrared light and provides a signal which represents the change in blood volume associated with each heartbeat.
The brain signal allows a number of clinically important end-points to be determined, including brain blood flow, oxygen and pressure levels.
The T-Pot (US) Study will be undertaken in patients that require invasive brain monitoring.
The primary aim of the study is to assess the accuracy of the brain pulse oximeter compared with the traditional invasive intracranial pressure (ICP) monitoring.
The brain signal allows a number of clinically important end-points to be determined, including brain blood flow, oxygen and pressure levels.
The T-Pot (US) Study will be undertaken in patients that require invasive brain monitoring.
The primary aim of the study is to assess the accuracy of the brain pulse oximeter compared with the traditional invasive intracranial pressure (ICP) monitoring.
Detailed Description:
The device is a non-invasive brain pulse oximeter It uses red and near-infrared light and provides a signal which represents the change in blood volume associated with each heartbeat
The brain signal allows a number of clinically important end-points to be determined including brain blood flow oxygen and pressure levels
The T-Pot US Study will be undertaken in patients that require invasive brain monitoring
The primary aim of the study is to assess the accuracy of the brain pulse oximeter compared with the traditional invasive intracranial pressure ICP monitoring
The brain signal allows a number of clinically important end-points to be determined including brain blood flow oxygen and pressure levels
The T-Pot US Study will be undertaken in patients that require invasive brain monitoring
The primary aim of the study is to assess the accuracy of the brain pulse oximeter compared with the traditional invasive intracranial pressure ICP monitoring
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