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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04869826

Enrollment

200

Registered

2021-05-03

Start date

2021-06-15

Completion date

2023-12-31

Last updated

2023-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

Hypertension, Blood pressure, Telemedicine, Telemonitoring, Vital sign monitoring

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 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.

Interventions

DEVICEPulsewave 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.

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Adults ≥ 19 years of age (minimum 30% male/female) * Wrist circumference between 13.5 cm. - 23 cm. (5.3 in. - 9.1 in.): Specifically for this test device, the wrist size of the consented participants will be distributed accordingly for a Gaussian distribution: Lowest Octile: ≥ 13.5cm to \< 14.7cm Lower Quarter: ≥ 13.5cm to \< 15.9cm Lower-Middle Quarter: ≥ 15.9cm to \< 18.3cm Upper-Middle Quarter: ≥ 18.3cm to \< 20.7cm Upper Quarter: ≥ 20.7cm to ≤ 23.0cm Highest Octile: ≥ 21.9cm to ≤ 23.0cm ● Willing to volunteer to participate and to sign the study specific informed consent form

Exclusion criteria

* Wrist circumference less than 13.5 cm. (5.3 in.) or greater than 23 cm. (9.1 in) * Hand or body tremors * Irregular heart rhythm (bigeminy, trigeminy, isolated ventricular premature beat (VPB), atrial fibrillation) * Korotkoff sound K5 not audible * Pregnant * A musculoskeletal disorder that prevents a non-invasive device to be inflated/deflated on the arm * Unwilling to volunteer to participate and to sign the study specific informed consent form

Design outcomes

Primary

Measure	Time frame	Description
Systolic Pressure	From the start of cuff inflation to the end of cuff deflation (approximately 60 seconds)	Non-invasive Pulsewave Health Monitor (PAD-2A) wrist cuff blood pressure device (mmHg)
Diastolic Pressure	From the start of cuff inflation to the end of cuff deflation (approximately 60 seconds)	Non-invasive Pulsewave Health Monitor (PAD-2A) wrist cuff blood pressure device (mmHg)

Countries

Canada

Contacts

Primary ContactChristie Aguiar, PhD

christie.aguiar@CloudDX.com506-977-2712

Backup ContactKeith R. Brunt, PhD

keith.brunt@dal.ca506-636-6974

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026