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Safety and efficacy validation clinical trial protocol for wrist blood pressure monitors

Safety and efficacy validation clinical trial protocol for wrist blood pressure monitors

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300077475
Enrollment
Unknown
Registered
2023-11-09
Start date
2023-07-26
Completion date
Unknown
Last updated
2023-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Interventions

Gold Standard:Kirschner's sound double auscultation with mercury sphygmomanometer
Index test:The wrist blood pressure detector, systolic/diastolic blood pressure

Sponsors

Beijing Luhe Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Participants included in this clinical trial must meet all of the following criteria to be enrolled: 1) Age 18-75 years old, gender is not limited; 2) Systolic blood pressure range is 70-200mmHg, diastolic blood pressure range is 50-130mmHg; 3) Subjects willing to provide written informed consent.

Exclusion criteria

Exclusion criteria: Participants in this clinical trial will not be enrolled if they meet any of the following criteria: 1) Persons who do not have full capacity for civil conduct; 2) Subjects with prior severe arrhythmias (e.g., ventricular bisection, ventricular triple rate, atrial fibrillation, etc.); 3) Subjects after pacemaker implantation; 4) Subjects with a history of severe vasculitis, severe angiosclerosis, and severe cutaneous keratosis; 5) Subjects with prior peripheral artery disease; 6) The body of the measurement site has wounds; 7) Participants who have participated in clinical trials or are participating in other clinical trials within the past month.

Design outcomes

Primary

MeasureTime frame
Systolic/diastolic blood pressure;Accuracy;Consistency;

Secondary

MeasureTime frame
Convenience and comfort;

Countries

China

Contacts

Public ContactKuang Zemin

Beijing Luhe Hospital, Capital Medical University

kzmkk@foxmail.com+86 185 1386 1179

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026