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OpenTrials
Completed

NCT Number: NCT03130686

A Clinical Evaluation of Omron Digital Blood Pressure Monitor

The purpose of this study is to measure the blood pressure level of the patients, using a cuff ranged 17 - 50 cm.

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Key information

Conditions

Blood Pressure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

OMRON HEALTHCARE CO., Ltd.

Mukō, 6170002, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Upper arm circumference: 17-50cm

Exclusion criteria

  • Patients who has arrhythmia.
  • When body motion is observed during measurement.
  • Korotkoff sound is poor quality.
  • Patient's arm circumference is outside cuff range.
  • Patient's auscultatory systolic blood pressure readings differ by more than 12mmHg. and patient's diastolic blood pressure readings differ by more than 8mmHg.
  • Patients stated they did not wish to continue with the study and it is stopped before completion.

Treatment and study plan

OMRON blood pressure monitor HEM-9210T

Device

To measure systolic blood pressure, diastolic blood pressure and pulse rate in patients.

Primary outcomes

  1. Verify the accuracy of measure functions of device

    Time frame: 30 days

    The aims of this study was to assess the accuracy of the Omron blood pressure monitor according to the ANSI/AAMI/ISO81060-2:2013. And it is analyzed and evaluated at least 85 patients based on the AAMI/ANSI/ISO81060-2:2013.

Sponsors and collaborators

Lead sponsor

Omron Healthcare Co., Ltd.

Industry

Collaborators

  • Biwako Chuo Hospital Japan
  • Shared Care Research and Education Consulting,. Inc. US

Registry information

Official study title

A Clinical Evaluation of OMRON Digital Blood Pressure Monitor, HEM-9210T, Blood Pressure Measurement Accuracy Based on Auscultation

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Apr 26, 2017
Registry last updated
Apr 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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