Ignite Creation Date:
2024-05-06 @ 6:58 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05853380
Status:
COMPLETED
Last Update Posted:
2023-07-03
First Post:
2023-05-02
Brief Title:
A Multi-Center Prospective Open Label Study of a Web-based Application for Pulse Rate in Adult Patients
Sponsor:
Mindset Medical
Organization:
Mindset Medical
Study Overview
Official Title:
A Multi-Center Prospective Open Label Study of a Web-based Application for Pulse Rate in Adult Patients
Status:
COMPLETED
Status Verified Date:
2023-06
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:
Evaluating the Accuracy of a Web-Based Application - Vital Sign Measurement Platform Description This single-arm cohort open-label and multi-center study is designed to evaluate the accuracy of a web-based application designed for measurements of vital signs including pulse rate PR It is hypothesized that the accuracy of the App is non-inferior to the accuracy of an FDA-clearedapproved vital sign monitoring device reference device
Detailed Description:
None
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