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

Huawei Device

Status: Completed

Conditions: Blood Pressure

Treatments: Device: Wrist Ambulatory Blood Pressure Monitor

Study type: Interventional

Funder types: Industry

Identifiers

NCT06573216

CTP-PPA0971CHN24011810332987

Details and patient eligibility

About

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.

Enrollment: 128 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

128 participants in 1 patient group

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

Experimental group

Treatment:

Device: Wrist Ambulatory Blood Pressure Monitor