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

NCT04869826 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2023-02-21

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Cloud DX Inc.

    collaborator INDUSTRY

  • Horizon Health Network

    collaborator OTHER

  • New Brunswick Health Research Foundation

    collaborator OTHER

  • Dalhousie University

    collaborator OTHER

  • Cardiovascular Research New Brunswick

    lead OTHER

Principal Investigators

  • Martin MacKinnon, MD, FRCP(C) · Complicated Hypertension Clinic, Saint John Regional Hospital

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-06-15
Primary Completion
2023-12-31
Completion
2023-12-31
FDA Device
Yes

Countries

  • Canada

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04869826 on ClinicalTrials.gov