NCT03130686

Brief Summary

The purpose of this study is to measure the blood pressure level of the patients, using a cuff ranged 17 - 50 cm.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
92

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2015

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

December 21, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 18, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2016

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

April 17, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 26, 2017

Completed
Last Updated

April 26, 2017

Status Verified

April 1, 2017

Enrollment Period

2 months

First QC Date

April 17, 2017

Last Update Submit

April 24, 2017

Conditions

Blood Pressure

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

OMRON blood pressure monitor HEM-9210TDEVICE

To measure systolic blood pressure, diastolic blood pressure and pulse rate in patients.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Resident of a community

You may qualify if:

  • Upper arm circumference: 17-50cm

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

OMRON HEALTHCARE CO., Ltd.

Mukō, 6170002, Japan

Location

Study Design

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

Study Record Dates

First Submitted

April 17, 2017

First Posted

April 26, 2017

Study Start

December 21, 2015

Primary Completion

February 18, 2016

Study Completion

March 31, 2016

Last Updated

April 26, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

No plan to share the data.

Locations

JP(1)