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Clinical validation trial of Omron electronic blood pressure monitor (HBP-1320).

Clinical validation trial of Omron electronic blood pressure monitor (HBP-1320).

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400091092
Enrollment
Unknown
Registered
2024-10-21
Start date
2024-10-28
Completion date
Unknown
Last updated
2024-10-28

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

Conditions

hypertension

Interventions

Sponsors

Zhongshan Hospital, Fudan University; Jiading Town Community Health Service Center, Jiading District, Shanghai
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Children over 3 years old and adults; 2. The circumference of the subject's arm is between 12-42cm; 3. Not participating in other clinical trials within one week; 4. Good compliance, voluntarily participate in this trial, and sign a written informed consent form (subjects under 18 years old are signed by their guardians).

Exclusion criteria

Exclusion criteria: 1. Subjects who have difficulty measuring blood pressure due to cutaneous reasons. 2. Women who are pregnant at the time of study participation. 3. Subjects implanted with pacemakers or defibrillators. 4. Subjects who have difficulty measuring blood pressure in a seated position. 5. Subjects with arteriovenous shunts or endovascular access in either arm. 6. Subject suffers from any form of arrhythmia symptoms. 7. Subjects who have not signed the informed consent form or are considered inappropriate by the investigator to participate in this clinical trial. 8. Children who are physically moving or crying during the test. 9. Those whose blood pressure fluctuates too much due to their own factors.

Design outcomes

Primary

MeasureTime frame
The accuracy of Blood Pressure value measurement;Accuracy;Sensitivity;Specificity;

Secondary

MeasureTime frame
Positive predicative value;

Countries

China

Contacts

Public ContactHong Jiang, Wuquan Huang

Department of Cardiology, Zhongshan Hospital, Fudan University; Jiading Town Community Health Service Center, Jiading District, Shanghai

jiang.hong@zs-hospital.sh.cn+86 21 6404 1990

Outcome results

None listed

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