NCT07094126

Brief Summary

The purpose of this study is to verify the accuracy of the three (3) cuffs with blood pressure monitor device.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2023

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

October 8, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 29, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 29, 2023

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

July 23, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 30, 2025

Completed
Last Updated

July 30, 2025

Status Verified

July 1, 2025

Enrollment Period

3 months

First QC Date

July 23, 2025

Last Update Submit

July 23, 2025

Conditions

Blood Pressure

Outcome Measures

Primary Outcomes (1)

  • Blood Pressure Monitor Accuracy

    All the test results of the electronic blood pressure monitor with three (3) cuffs is within the accuracy creteria, with the merury sphygmomanometer as control

    30 minutes

Study Arms (1)

Subject use both KD-595 Blood Pressure Monitor 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, the Air Force Medical University

Xi’an, Shanxi, China

Location

Study Design

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

Study Record Dates

First Submitted

July 23, 2025

First Posted

July 30, 2025

Study Start

October 8, 2023

Primary Completion

December 29, 2023

Study Completion

December 29, 2023

Last Updated

July 30, 2025

Record last verified: 2025-07

Locations

CN(1)