Ignite Creation Date:
2024-05-06 @ 4:04 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04869826
Status:
RECRUITING
Last Update Posted:
2023-02-21
First Post:
2021-04-28
Brief Title:
Calibration of a Wrist Cuff Blood Pressure Device According to the AAMIESHISO Universal Standard
Sponsor:
Cardiovascular Research New Brunswick
Organization:
Cardiovascular Research New Brunswick
Study Overview
Official Title:
Calibration of the Cloud DX Pulsewave Health Monitor PAD-2A Oscillometric Wrist Cuff Home Blood Pressure Monitor According to the AAMIESHISO Universal Standard ISO 81060-2 AMD_2020 CCV-4
Status:
RECRUITING
Status Verified Date:
2023-02
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 objective of this study is to calibrate the blood pressure measurements of the Pulsewave Health Monitor PAD-2A device to be within 58 mmHg of the average of the dual-observer measurements via an aneroid sphygmomanometer reference device as per the methodology described in the ISO 81060-2 AMD_2020 protocol
Detailed Description:
The plan for this study is to calibrate the blood pressure measurements of the PAD-2A device with the dual-observer blood pressure measurements via an aneroid sphygmomanometer reference device as per the ISO 81060-2 AMD_2020 protocol The data will be collected and analyzed in order to calibrate the PAD-2A device blood pressure measurements to be within 58 mmHg of the average of the dual-observer auscultatory blood pressure measurements by adjusting the device algorithm
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| STP-PW2-002 | OTHER | Health Canada | None |