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

NCT ID: NCT06573216

Last Updated: 2024-08-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-24
• Study Completion Date: 2024-06-04

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Wrist Ambulatory Blood Pressure Monitor

Intervention Type: DEVICE

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

Interventions

Wrist Ambulatory Blood Pressure Monitor

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Subjects should voluntarily participate in the clinical trial and sign the informed consent form;

2. Subjects must be willing and able to follow the study procedures;

3. Subjects are over 18 years old whose wrist circumference should be within 13.0-21.0cm.

Exclusion Criteria

1. 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;

2. Subjects with sickle cell disease;

3. Subjects with prior mastectomy or arm lymph node dissection;

4. Subjects who are allergic to nylon, fluororubber or thermo-plastic polyurethane elastomer (TPU);

5. Subjects with wounds on the limb at the measurement site or inflammation of the wrist

6. Subjects who are undergoing intravenous fluid therapy, blood transfusion or other catheterization at the measurement site limb;

7. Subjects who have eaten, consumed alcohol, smoked cigarettes, or exercised vigorously 30 minutes prior to the trial;

8. Subjects who have participated in other clinical trials within 30 days that may affect this trial;

9. Subjects who, in the opinion of the investigator, should not participate in this clinical trial.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Huawei Device Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Bin Peng

Chenzhou, Hunan, China

Countries

China

Other Identifiers

CTP-PPA0971CHN24011810332987

Identifier Type: -

Identifier Source: org_study_id