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

NCT06573216 | Completed

• 1 other identifier: CTP-PPA0971CHN24011810332987
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Blood Pressure

Outcome Measures

Primary Outcomes (3)

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

  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.

  30 minutes

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

  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.

  30 minutes

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

  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.

  30 minutes

Study Arms (1)

Blood pressure measured by wrist ambulatory blood pressure monitor and mercury sphygmomanometer

EXPERIMENTAL

Device: Wrist Ambulatory Blood Pressure Monitor

Interventions

Wrist Ambulatory Blood Pressure Monitor DEVICE

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

Blood pressure measured by wrist ambulatory blood pressure monitor and mercury sphygmomanometer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Huawei Device Co., Ltd: lead

Study Sites (1)

Bin Peng

Chenzhou, Hunan, 423000, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: August 27, 2024
• Study Start: April 24, 2024
• Primary Completion: June 4, 2024
• Study Completion: June 4, 2024
• Last Updated: August 27, 2024

Record last verified: 2024-08

Locations

CN (1)