Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06565780
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-19
Brief Title:
Evaluation of the Performance and Safety of the Aktiia Spot-check Optical Blood Pressure Monitoring Device at Wrist Against Double Auscultation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of the Performance and Safety of the Aktiia Spot-check Optical Blood Pressure Monitoring OBPM Device at Wrist Against Double Auscultation a Multicentric Prospective Clinical Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
This study with N 85 participants minimum over 8 visits spread over 23 hours has been designed to assess the accuracy and precision of the Blood Pressure and pulse rate values as generated by Aktiiaproduct-G0 for up to 23 hours after initialization in a cohort of subjects representative of the US population
For the study subjects will be asked to stay seated while measurements are taken at different timepoints
For the study subjects will be asked to stay seated while measurements are taken at different timepoints
Detailed Description:
None
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