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Clinical Trial Summary

This is a study of adult patients with a severe and sudden brain injury who have a drain placed in their brain to measure pressure. The purpose of the study is to monitor the pressure in the brain using a monitor placed on the forehead, and compare this to a drain placed in the brain.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06267131
Study type Interventional
Source Cyban Pty Ltd
Contact Catherine Hassett, DO
Phone 866.320.4573
Email HASSETC@ccf.org
Status Recruiting
Phase N/A
Start date October 27, 2023
Completion date November 2024

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