NCT05551845

Brief Summary

The purpose of this study is to verify the accuracy of the 4 blood pressure cuffs with blood pressure monitor device. Cuff circumference is : 15cm-24cm, 20cm-34cm, 30cm-44cm, 22cm-42cm

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 7, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 20, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 23, 2022

Completed
Last Updated

July 28, 2023

Status Verified

October 1, 2022

Enrollment Period

3 months

First QC Date

September 20, 2022

Last Update Submit

July 26, 2023

Conditions

Blood Pressure

Outcome Measures

Primary Outcomes (1)

  • blood pressure monitor accuracy

    All the test results of the electronic blood pressure monitor with 4 cuffs is within the accuracy creteria, with the merury sphygmomanometer as control

    30minutes

Study Arms (1)

Subject use both KD-595 Arm Automatic Electronic BPM and mercury sphygmomanometers

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Normal blood pressure and hypertensive patients over 12 years old

You may qualify if:

  • Normal blood pressure and hypertensive patients over 12 years old

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine

Tianjin, China

Location

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2022

First Posted

September 23, 2022

Study Start

April 7, 2021

Primary Completion

June 30, 2021

Study Completion

March 1, 2022

Last Updated

July 28, 2023

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)