Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2026-01-01 @ 11:50 PM
Study NCT ID:
NCT06581835
Status:
COMPLETED
Last Update Posted:
2025-07-25
First Post:
2024-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Accuracy Performance Verification of the INVOS™ PM7100 System in Adults
Sponsor:
Medtronic - MITG
Organization:
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:
COMPLETED
Status Verified Date:
2024-07
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:
None
Brief Summary:
Prospective, observational, post-market, verification study to ensure compliance to the ISO 80601-2-85:2021 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 and/or 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:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: