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Calibration of a Wrist Cuff Blood Pressure Device, According to the AAMI/ESH/ISO Universal Standard | Clinical Trials | Clareo Health

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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)

NCT04869826•Cardiovascular Research New Brunswick

View on ClinicalTrials.gov

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.

Eligibility

Age

19 - No limit years

Sex

ALL

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

Locations (1)

Horizon Health Network

Saint John, Canada

Key Dates

Start Date

June 15, 2021

Primary Completion Date

December 31, 2023

Completion Date

December 31, 2023

Last Updated

February 21, 2023

Enrollment

200

ESTIMATED participants

Conditions

Hypertension

Interventions

Pulsewave Health Monitor (PAD-2A) Device

DEVICE

Contacts

Christie Aguiar, PhD

CONTACT

506-977-2712 christie.aguiar@CloudDX.com

Keith R. Brunt, PhD

CONTACT

506-636-6974 keith.brunt@dal.ca

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Cystic FibrosisImmunologic Deficiency Syndrome+3 more

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RECRUITING

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 21, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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