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Validation Study of CONTEC08C Electronic Sphygmomanometer

Not Applicable
Recruiting
Conditions
Blood Pressure
Registration Number
NCT06457568
Lead Sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital
Brief Summary

The purpose of this study is to assess the accuracy of the CONTEC08C automated oscillometric upper-arm sphygmomanometer in the general population for clinical use according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension /International Organization for Standardization (AAMI/ESH/ISO) Universal Standard (ISO 81060-2:2018).

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
100
Inclusion Criteria
  • Subjects aged 12 to 79 years
  • Subjects voluntarily participate in the clinical trial and sign the informed consent.
Exclusion Criteria
  • Subjects with cardiac arrhythmias;
  • Pregnancy;
  • Poor quality Korotkoff sounds;
  • Subject with an arm injury incompatible with the use of a cuff-based sphygmomanometer;
  • Other conditions that the investigator considers ineligible for clinical trial.

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
Blood pressure measurement data30mintues

Systolic Blood Pressure and Diastolic Blood Pressure

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Chinese Academy of Medical Sciences,Fuwai Hospital

🇨🇳

Beijing, Beijing, China

Chinese Academy of Medical Sciences,Fuwai Hospital
🇨🇳Beijing, Beijing, China
Ying Lou, MD
Principal Investigator

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