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CompletedNCT06117787Updated Nov 7, 2023

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

An observational study in Blood Pressure, sponsored by Andon Health Co., Ltd. Completed at 1 site in China. Open to participants aged 12 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-07.

Sponsored by Andon Health Co., Ltd · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
90
Ages
12 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Blood Pressure
03

In context

Lead sponsor

Andon Health Co., Ltd is the lead sponsor of 19 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Normal blood pressure and hypertensive patients over 12 years old.

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
90 participants (actual)
Patient registry
No

Groups and cohorts

  • Subject use both KD-7920 Wrist Automatic Electronic BPM and mercury sphygmomanometers
06

What researchers measure

Primary outcomes

  1. blood pressure monitor accuracy

    All the test results of the electronic blood pressure monitor with the cuff is within the accuracy creteria, with the merury sphygmomanometer as control

    Time frame: 30 minutes

07

Study locations

1 site
  • The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
    Tianjin, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 7, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06117787
Lead sponsor
Andon Health Co., Ltd
Responsible party
Sponsor
First posted
Nov 7, 2023
Start date
Apr 2, 2022
Primary completion
May 28, 2023
Completion
May 28, 2023
Last update
Nov 7, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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