Ignite Creation Date:
2025-12-25 @ 4:35 AM
Ignite Modification Date:
2026-03-14 @ 5:53 AM
Study NCT ID:
NCT06586918
Status:
COMPLETED
Last Update Posted:
2024-10-26
First Post:
2024-09-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Perfusion Index Parameter
Sponsor:
Medtronic - MITG
Organization:
Study Overview
Official Title:
Verification of a Perfusion Index Parameter in Adult Volunteers
Status:
COMPLETED
Status Verified Date:
2024-09
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:
To evaluate the association between the Perfusion index parameter and an independent measure of perfusion.
Detailed Description:
Perfusion index parameters measured with an Investigational Pulse Oximetry PCBA, paired with Market Released sensors, will be compared to perfusion levels measured by a FDA-cleared device equipped with a laser Doppler technology-based device for blood perfusion measurements. Continuous Perfusion index measurements will be taken during the test sequence.
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?:
None
Is an FDA AA801 Violation?: