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Validation Study of CONTEC08C Electronic Sphygmomanometer

Validation of the CONTEC08C Oscillometric Blood Pressure Monitor in General Population According to the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018)

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06457568
Enrollment
100
Registered
2024-06-13
Start date
2024-05-25
Completion date
2024-08-01
Last updated
2024-06-24

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

Conditions

Blood Pressure

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).

Interventions

DIAGNOSTIC_TESTBlood pressure measurement

The blood pressure measurement was taken simultaneously by two observers using mercury sphygmomanometer and by a supervisor using the tested device, CONTEC08C.

Sponsors

Chinese Academy of Medical Sciences, Fuwai Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
12 Years to 79 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Blood pressure measurement data30mintuesSystolic Blood Pressure and Diastolic Blood Pressure

Countries

China

Contacts

Primary ContactYing Lou, MD
fuwailou1798@sina.com86(10)88392170

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026