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Device
Enrolled patients for Traumatic Brain Injury (T-POT US Trial)
N/A
Recruiting
Led By Catherine Hassett, DO
Research Sponsored by Cyban Pty Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adult brain-injured patients who have undergone external ventricular drain insertion for cerebrospinal fluid drainage and invasive intracranial pressure monitoring as part of standard medical care
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up daily recordings for up to 30 days while the patient has an invasive icp probe in situ
Awards & highlights
T-POT US Trial Summary
"This trial is looking at adult patients with a serious brain injury who have a drain inserted to measure pressure. They want to see if monitoring pressure with a device on the forehead is as effective as using the
Who is the study for?
This trial is for adults with severe traumatic brain injury who already have a drain in their brain to monitor pressure. It's designed to test if a non-invasive forehead monitor can effectively measure brain pressure compared to the standard invasive method.Check my eligibility
What is being tested?
The study is testing a new device called Brain Pulse Oximeter, which is placed on the patient's forehead to monitor brain pressure without needing surgery, and comparing its accuracy with the traditional drain-based method.See study design
What are the potential side effects?
Since this trial involves monitoring devices rather than medication or surgical intervention, there are minimal side effects expected. The main concern would be potential skin irritation from the adhesive used to attach the oximeter.
T-POT US Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I've had a procedure to drain fluid from my brain and monitor pressure.
T-POT US Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ daily recordings for up to 30 days while the patient has an invasive icp probe in situ
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~daily recordings for up to 30 days while the patient has an invasive icp probe in situ
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Agreement of the brain oximeter levels compared with invasive ICP levels
Secondary outcome measures
Optical signal changes associated with non-convulsive seizures via EEG monitoring (Alpha, Beta, Theta)
Optical signal changes associated with periods of brain hypoxia and surrogate ICP waveform
T-POT US Trial Design
1Treatment groups
Experimental Treatment
Group I: Enrolled patientsExperimental Treatment1 Intervention
All enrolled patients will have brain pulse monitoring
Find a Location
Who is running the clinical trial?
Cyban Pty LtdLead Sponsor
1 Previous Clinical Trials
21 Total Patients Enrolled
Catherine Hassett, DOPrincipal InvestigatorThe Cleveland Clinic
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the current number of individuals being recruited for participation in this clinical investigation?
"Yes, as per clinicaltrials.gov, this trial is currently seeking participants. The initial posting date was 10/27/2023 and the most recent update was on 2/18/2024. The study aims to enroll 15 individuals at a single site."
Answered by AI
Are new patients currently being enrolled in this ongoing clinical trial?
"Per clinicaltrials.gov, this investigation is presently open to potential participants. The trial's initial posting was on October 27th, 2023, with the most recent update noted on February 18th, 2024."
Answered by AI
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