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Completed

NCT Number: NCT04379323

Clinical Trial of YuWell YE900 Electronic Sphygmomanometer

The purpose of this study is to evaluate the accuracy of the YuWell YE900 medical electronic blood pressure monitor for blood pressure measurements in adults and children according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Universal Standard (ISO 81060-2:2018).

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Key information

Conditions

Blood Pressure

Age range

3 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210011, China

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 3 Years and older (Child, Adult, Older Adult);
  • Subjects voluntarily participate in the clinical trial and sign the informed consent.

Exclusion criteria

  • Disturbance of consciousness;
  • Patients requiring hemodialysis;
  • Taking anticoagulant drugs due to cardiovascular and cerebrovascular diseases;
  • Pregnant and lactating women;
  • Patients with cardiac arrhythmias;
  • Other conditions that the investigator considers ineligible for clinical trial.

Treatment and study plan

YuWell YE900 Electronic Sphygmomanometer

Diagnostic Test

Measurement blood pressure by YuWell YE900 Electronic Sphygmomanometer and Desk Mercury Sphygmomanometer.

Other names: Desk Mercury Sphygmomanometer, Blood Pressure Measurement

Primary outcomes

  1. Blood pressure measurement data

    Time frame: 30 minutes

    Systolic Pressure and Diastolic Pressure

Sponsors and collaborators

Lead sponsor

The Second Hospital of Nanjing Medical University

Other

Collaborators

  • Jiangsu Yuyue medical equipment & supply Co., Ltd.

Registry information

Official study title

Validation of the YuWell YE900 Medical Electronic Blood Pressure Monitor in Adults and Children According to the AAMI/ESH/ISO 81060-2:2018 Standard

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 7, 2020
Registry last updated
Aug 19, 2020

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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