Ignite Creation Date:
2024-05-06 @ 7:27 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06017687
Status:
RECRUITING
Last Update Posted:
2023-09-29
First Post:
2023-08-24
Brief Title:
Data Collection and Evaluation of OptiBP Under Investigational Use
Sponsor:
Biospectal
Organization:
Biospectal
Study Overview
Official Title:
Data Collection and Evaluation of a Mobile Machine-learning-based Solution for Blood Pressure Estimation - the OptiBP Study
Status:
RECRUITING
Status Verified Date:
2023-09
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:
The purpose of this study is to collect data to develop and evaluate the use of state-of-the-art machine learning approaches within a mobile phone application for the estimation of blood pressure
Detailed Description:
Participants will simultaneously acquire blood pressure measurements through a cuff-based automatic over-the-counter blood pressure monitor on the upper arm while recording an optical signal through the camera of a smartphone on the tip of the index of the opposite arm
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None