NCT04869826

Calibration of a Wrist Cuff Blood Pressure Device, According to the AAMI/ESH/ISO Universal Standard

Calibration of the Cloud DX Pulsewave Health Monitor (PAD-2A) Oscillometric Wrist Cuff Home Blood Pressure Monitor, According to the AAMI/ESH/ISO Universal Standard (ISO 81060-2: AMD_2020) (CCV-4)

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Cardiovascular Research New Brunswick · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Accepted

Summary

The objective of this study is to calibrate the blood pressure measurements of the Pulsewave Health Monitor (PAD-2A) device to be within 5±8 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 5±8 mmHg of the average of the dual-observer auscultatory blood pressure measurements by adjusting the device algorithm.

Conditions

• Hypertension

Interventions

Type	Name	Description
DEVICE	Pulsewave Health Monitor (PAD-2A) Device	This is an observational, comparison study of blood pressure measurements. The objective of this study is to calibrate the blood pressure measurements of the Pulsewave Health Monitor (PAD-2A) device to be within 5±8 mmHg of the average of the dual-observer auscultatory blood pressure measurements via an aneroid sphygmomanometer (reference device), as per the ISO 81060-2: AMD\_2020 universal protocol.

Timeline

• Start date: 2021-06-15
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2021-05-03
• Last updated: 2023-02-21

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated device study