Ignite Creation Date:
2024-10-25 @ 7:57 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06581835
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-23
Brief Title:
Accuracy Performance Verification of the INVOS PM7100 System in Adults
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Accuracy Performance Verification of the INVOS PM7100 System by Comparing RSO2 Values to Reference Blood Oxygen Saturation Measurements in Adult Human Volunteers
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Prospective observational post-market verification study to ensure compliance to the ISO 80601-2-852021 standard
Detailed Description:
The purpose of this study is to provide data for verification of the INVOS PM7100 System paired with the Adult Sensor PMSENS71-A Medtronic evaluates the performance andor feasibility of non-invasive optical devices over a clinically relevant range of arterial saturations This study evaluates rSO2 accuracy of tissue oximetry equipment compared directly to the actual saturation of arterial and jugular blood samples SaO2 and SjvO2 and the composite of the two SavO2 as measured by co-oximetry
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None