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Clinical Trial on the Accuracy of the FishLeap YE8100B Wrist-Worn Electronic Blood Pressure Monitor

Clinical Trial on the Accuracy of the FishLeap YE8100B Wrist-Worn Electronic Blood Pressure Monitor

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600116043
Enrollment
Unknown
Registered
2026-01-05
Start date
2026-01-05
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

None listed

Interventions

Gold Standard:The traditional mercury sphygmomanometer is used, with two observers using stethoscopes to auscultate simultaneously and recording the measured blood pressure values individually. The av
Index test:the wrist electronic blood pressure monitor

Sponsors

The First Affiliated Hospital of Anhui Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
12 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Gender distribution: At least 30% of the participants are male, and at least 30% of the participants are female; 2. Age distribution: Participants must be over 12 years old; 3. Wrist circumference distribution: (12.5 cm-21.5 cm) a) At least 20% of the subjects' wrist circumference should be within each quarter range of the total wrist circumference range; b) At least 10% of the subjects' wrist circumference should be within the upper eighth range of the total wrist circumference; c) At least 10% of the subjects' wrist circumference should be within the lower eighth range of the total wrist circumference; 4. Blood pressure distribution: a) At least 5% of the subjects should have a systolic blood pressure of = 160 mmHg (21.33 kPa); c) At least 20% of the subjects should have a systolic blood pressure of >= 140 mmHg (18.66 kPa); d) At least 5% of the subjects should have a diastolic blood pressure of = 100 mmHg (13.33 kPa); f) At least 20% of the subjects should have a diastolic blood pressure of >= 85 mmHg (11.33 kPa); The other blood pressure distributions are between these limit values (here, the blood pressure values are calculated based on the values read from the mercury sphygmomanometer); 5. Participants must be willing and able to follow the research steps and sign an informed consent form after understanding the research content; 6. Good compliance, able to cooperate in completing the entire clinical trial.

Exclusion criteria

Exclusion criteria: 1. Having mental illness, consciousness disorders, or other inability to cooperate with research; 2. People who require hemodialysis; 3. I am taking anticoagulant drugs due to cardiovascular and cerebrovascular diseases; 4. Pregnant and lactating women; 5. Patients with severe arrhythmia (such as atrial fibrillation, frequent premature beats) that may affect the accuracy of blood pressure measurement; 6. diabetic patients; 7. Patients with severe peripheral arterial disease that affects upper limb blood flow supply; 8. Those whose wrist circumference exceeds the coverage area of the wristband size; 9. Researchers believe that there are other situations that are not suitable for inclusion in the study.

Design outcomes

Primary

MeasureTime frame
Accuracy of wrist-worn electronic blood pressure monitors;

Secondary

MeasureTime frame
Relative error in pulse frequency;The relationship between wrist circumference and measurement error;

Countries

China

Contacts

Public ContactSong Bing

The First Affiliated Hospital of Anhui Medical University

yfy131822@fy.ahmu.edu.cn+86 551 6292 2343

Outcome results

None listed

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