Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06368206
Status:
COMPLETED
Last Update Posted:
2024-06-24
First Post:
2024-04-04
Brief Title:
Recording of Physiological Data Via an Optical Sensor at the Fingertip Alongside With Double Auscultatory and Pulse Oximetry to Evaluate the Effectiveness of an Optical Blood Pressure Monitoring OBPM
Sponsor:
Aktiia SA
Organization:
Aktiia SA
Study Overview
Official Title:
Recording of Physiological Data Via an Optical Sensor at the Fingertip Alongside With Double Auscultatory and Pulse Oximetry to Evaluate the Effectiveness of an Optical Blood Pressure Monitoring OBPM Algorithm That Requires no Calibration With an External Cuff a Single-center Prospective Clinical Study
Status:
COMPLETED
Status Verified Date:
2024-08
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:
The present study OBPM_Calfree2024 with N 85 participants minimum over 1 visit lasting around 1h has been designed to collect raw optical data with Aktiiaproduct-G2C Clinical investigational system together with several reference systems within a cohort of subjects characterized by a wide variety of phenotypes
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None