Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06574113
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-23
Brief Title:
Validation of Cuffless Blood Pressure Measurements Using the Perin Health Patch
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Validation of Cuffless Blood Pressure Measurements Using the Perin Health Patch
Status:
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 aims to validate a proprietary cuffless blood pressure algorithm using measurements from a multi-modal chest-worn medical device the Perin Health Patch PHP
Detailed Description:
The study will compare the performance of the PHP to an ambulatory blood pressure cuff across 85 subjects for a 10-minute monitoring period followed by an optional cold pressor test and an additional 10-minute monitoring period The study aims to confirm that the calibrated measurement from the wearable device meets AAMI performance standards
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