Validation Study of CONTEC08C Electronic Sphygmomanometer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-25

Study Completion Date

2024-08-01

Brief Summary

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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).

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Detailed Description

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Conditions

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Blood Pressure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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CONTEC08C and mercury sphygmomanometer

Blood Pressure Measurement with the CONTEC08C Oscillometric Sphygmomanometer (CONTEC08C) and with Mercury Sphygmomanometer

Group Type EXPERIMENTAL

Blood pressure measurement

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Blood pressure measurement

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.

Minimum Eligible Age

12 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes