Status:
COMPLETED
Clinical Trial of Wrist Ambulatory Blood Pressure Monitor in Conformance With the EN ISO 81060-2:2018+AMD1:2020
Lead Sponsor:
Huawei Device Co., Ltd
Conditions:
Blood Pressure
Eligibility:
All Genders
18+ years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 24 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 4 2024
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT06573216
Start Date
April 24 2024
End Date
June 4 2024
Last Update
August 27 2024
Active Locations (1)
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1
Bin Peng
Chenzhou, Hunan, China, 423000