Blood Pressure Monitor Clinical Test (Cuff Range: 13.5cm-19.5cm）

October 31, 2023 updated by: Andon Health Co., Ltd

Blood Pressure Monitor#Model#KD-7920#Clinical Test

The purpose of this study is to verify the accuracy of the blood pressure cuffs with blood pressure monitor device.

Cuff circumference is 13.5cm-19.5cm.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Tianjin, China
        • The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Normal blood pressure and hypertensive patients over 12 years old.

Description

Inclusion Criteria:

  • Normal blood pressure and hypertensive patients over 12 years old.

Exclusion Criteria:

  • Patients with serious arrhythmias or a high frequency of arrhythmias
  • Pregnant woman
  • Other investigators believe that it is not suitable to participate in this clinical trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Subject use both KD-7920 Wrist Automatic Electronic BPM and mercury sphygmomanometers

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
blood pressure monitor accuracy
Time Frame: 30 minutes
All the test results of the electronic blood pressure monitor with the cuff is within the accuracy creteria, with the merury sphygmomanometer as control
30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Andon Health Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 2, 2022

Primary Completion (Actual)

May 28, 2023

Study Completion (Actual)

May 28, 2023

Study Registration Dates

First Submitted

October 31, 2023

First Submitted That Met QC Criteria

October 31, 2023

First Posted (Actual)

November 7, 2023

Study Record Updates

Last Update Posted (Actual)

November 7, 2023

Last Update Submitted That Met QC Criteria

October 31, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • Andon Health 13

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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