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Completed

NCT Number: NCT06573216

Clinical Trial of Wrist Ambulatory Blood Pressure Monitor in Conformance With the EN ISO 81060-2:2018+AMD1:2020

The accuracy and safety of the Wrist Ambulatory Blood Pressure Recorder (Model: LCA-B10) were assessed according to the requirements of EN ISO 81060-2:2018 + AMD1:2020.

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Key information

Conditions

Blood Pressure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bin Peng

Chenzhou, Hunan, 423000, China

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Subjects should voluntarily participate in the clinical trial and sign the informed consent form;
  • Subjects must be willing and able to follow the study procedures;
  • Subjects are over 18 years old whose wrist circumference should be within 13.0-21.0cm.

Exclusion criteria

  • Subjects with serious arrhythmias (atrial fibrillation, atrial flutter, ventricular flutter, ventricular fibrillation, ventricular tachycardia, borderline tachycardia, sinus arrest, pathological sinus syndrome, pacemaker rhythm) showed by electrocardiogram during screening period;
  • Subjects with sickle cell disease;
  • Subjects with prior mastectomy or arm lymph node dissection;
  • Subjects who are allergic to nylon, fluororubber or thermo-plastic polyurethane elastomer (TPU);
  • Subjects with wounds on the limb at the measurement site or inflammation of the wrist
  • Subjects who are undergoing intravenous fluid therapy, blood transfusion or other catheterization at the measurement site limb;
  • Subjects who have eaten, consumed alcohol, smoked cigarettes, or exercised vigorously 30 minutes prior to the trial;
  • Subjects who have participated in other clinical trials within 30 days that may affect this trial;
  • Subjects who, in the opinion of the investigator, should not participate in this clinical trial.

Treatment and study plan

Wrist Ambulatory Blood Pressure Monitor

Device

Comparing blood pressure measured by wrist blood pressure monitor with mercury sphygmomanometer .

Primary outcomes

  1. Blood pressure mean deviation and standard deviation- evaluation criterion 1

    Time frame: 30 minutes

    The mean deviation and standard deviation between the blood pressure values measured by the investigational device and those obtained using the auscultatory method with the reference device. This calculation is performed on valid data pairsof subjects (n≥255).

    Evaluation criterion 1: The blood pressure mean deviation should not exceed ±5mmHg, and the standard deviation should not exceed 8mmHg.

  2. Blood pressure mean deviation and standard deviation- evaluation criterion 2

    Time frame: 30 minutes

    The mean deviation and standard deviation between the blood pressure values measured by the investigational device and those obtained using the auscultatory method with the reference device. This calculation is performed on the valid data group of all subjects (m≥85).

    Evaluation criterion 2: The blood pressure standard deviation within the valid data group (m ≥ 85) should not exceed the maximum allowable standard deviation corresponding to the mean deviation listed in Criterion 2 in section 5.2.4.1.2 b of ISO 81060-2:2018+AMD1:2020.

  3. The mean deviation and standard deviation of blood pressure measurements under ambulatory blood pressure monitoring

    Time frame: 30 minutes

    The mean deviation and standard deviation of the blood pressure within the valid data group are calculated to evaluate whether the clinical accuracy of the investigational device meets the requirements outlined in ISO 81060-2:2018+AMD1:2020, specifically in section 5.2.4.1.2a).

    The blood pressure mean deviation should not exceed ±5mmHg, and the standard deviation should not exceed 8mmHg.

Sponsors and collaborators

Lead sponsor

Huawei Device Co., Ltd

Industry

Registry information

Official study title

Clinical Trial on the Effectiveness and Safety of Blood Pressure Function System of Wrist Ambulatory Blood Pressure Monitor

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 27, 2024
Registry last updated
Aug 27, 2024

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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