Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-25 @ 4:27 AM
Study NCT ID:
NCT06657820
Status:
WITHDRAWN
Last Update Posted:
2025-06-13
First Post:
2024-10-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Optical Brain Pulse Monitor: Validation Of Cerebral Oximetry Monitoring (OBPM:VOCOM) Study.
Sponsor:
Elliot Teo
Organization:
Study Overview
Official Title:
Optical Brain Pulse Monitor: Validation Of Cerebral Oximetry Monitoring (OBPM: VOCOM) Study.
Status:
WITHDRAWN
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The decision was made to withdraw this study prior to recruitment to make further changes to the investigational device.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OBPM:VOCOM
Brief Summary:
The purpose of this study is to calibrate and validate a cerebral oximeter product from Cyban Pty. Ltd. The study will involve comparing cerebral oximeter signals against reference arterial and jugular bulb blood gas measures.
Detailed Description:
The primary objective of the study is to measure the absolute and relative accuracy of the StO2 device by comparing the NIRS-derived brain tissue oxygen saturation with blood-referenced CO-oximeter oxygen saturation values. The CO-oximeter oxygen saturation values from paired arterial and jugular bulb blood samples are combined into a weighted-equation to derive the reference SavO2. Accuracy is reported over a range of oxygen saturations with study subjects exposed to a controlled oxygen desaturation with serial sampling of paired arterial and internal jugular venous blood gas samples.
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?: