Blood Pressure Monitor Clinical Test (Cuff Range: 15-24,2... | NCT05551845

Studies
Blood Pressure Monitor Clinical Test (Cuff Range: 15-24,20-34,30-44,22-42）

NCT05551845

Sponsor

Andon Health Co., Ltd

Status

Completed

Last Update Posted

Jul 28, 2023Actual

Enrollment

90Actual

Phase

Not provided

Conditions

Blood Pressure

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 7, 2021Actual

Primary Completion Date

Jun 30, 2021Actual

Completion Date

Mar 1, 2022Actual

First Submitted Date

Sep 20, 2022

First Submission Date that Met QC Criteria

Sep 20, 2022

First Posted Date

Sep 23, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 26, 2023

Last Update Posted Date

Jul 28, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

90Actual

Label	Type	Description	Intervention Names
Subject use both KD-595 Arm Automatic Electronic BPM and mercury sphygmomanometers

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Normal blood pressure and hypertensive patients over 12 years old

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine		Tianjin			China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided