A Clinical Evaluation of Omron Digital Blood Pressure Mon... | NCT03130686

Studies
A Clinical Evaluation of Omron Digital Blood Pressure Monitor

NCT03130686

Sponsor

Omron Healthcare Co., Ltd.

Status

Completed

Last Update Posted

Apr 26, 2017Actual

Enrollment

92Actual

Phase

Not provided

Conditions

Blood Pressure

Interventions

OMRON blood pressure monitor HEM-9210T

Countries

Japan

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

Apr 2017

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

Dec 21, 2015Actual

Primary Completion Date

Feb 18, 2016Actual

Completion Date

Mar 31, 2016Actual

First Submitted Date

Apr 17, 2017

First Submission Date that Met QC Criteria

Apr 24, 2017

First Posted Date

Apr 26, 2017Actual

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

Apr 24, 2017

Last Update Posted Date

Apr 26, 2017Actual

Name	Class
Biwako Chuo Hospital Japan	UNKNOWN
Shared Care Research and Education Consulting,. Inc. US	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Yes

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

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

92Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
OMRON blood pressure monitor HEM-9210T	Device	To measure systolic blood pressure, diastolic blood pressure and pulse rate in patients.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Verify the accuracy of measure functions of device	The aims of this study was to assess the accuracy of the Omron blood pressure monitor according to the ANSI/AAMI/ISO81060-2:2013. And it is analyzed and evaluated at least 85 patients based on the AAMI/ANSI/ISO81060-2:2013.	30 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Upper arm circumference: 17-50cm

Exclusion Criteria:

Patients who has arrhythmia.
When body motion is observed during measurement.
Korotkoff sound is poor quality.
Patient's arm circumference is outside cuff range.
Patient's auscultatory systolic blood pressure readings differ by more than 12mmHg. and patient's diastolic blood pressure readings differ by more than 8mmHg.
Patients stated they did not wish to continue with the study and it is stopped before completion.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Resident of a community

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
OMRON HEALTHCARE CO., Ltd.		Mukō		6170002	Japan

IPD Sharing Statement Module

Plan to Share IPD

Description

No plan to share the data.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided