Blood PressureNCT03130686
A Clinical Evaluation of Omron Digital Blood Pressure Monitor
An observational study of Blood Pressure, run by Omron Healthcare Co., Ltd. at 1 site in Japan.
Trial summary
The purpose of this study is to measure the blood pressure level of the patients, using a cuff ranged 17 - 50 cm. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure
- What is being tested?
- OMRON blood pressure monitor HEM-9210T
- Type of treatment
- Medical device
- How many people
- 92 participants
- Where
- 1 siteJapan
- Study dates
- 21 Dec 2015to 31 Mar 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Resident of a community
Who may be able to join
- Upper arm circumference: 17-50cm
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Evaluation of OMRON Digital Blood Pressure Monitor, HEM-9210T, Blood Pressure Measurement Accuracy Based on Auscultation
The purpose of this study is to measure the blood pressure level of the patients, using a cuff ranged 17 - 50 cm.
- Conditions
- Blood Pressure
- Being tested
- OMRON blood pressure monitor HEM-9210T
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OMRON blood pressure monitor HEM-9210TDevice
To measure systolic blood pressure, diastolic blood pressure and pulse rate in patients.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2017
- Study start21 Dec 2015
- Primary completion18 Feb 2016
- Study completion31 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Omron Healthcare Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biwako Chuo Hospital Japan, Shared Care Research and Education Consulting,. Inc. US
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03130686
- Sponsor's protocol ID
- HDV-TCD-150311
- Status last verified
- Apr 2017
- First submitted
- 17 Apr 2017
- Last updated
- 26 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No plan to share the data.
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Evaluation of OMRON Digital Blood Pressure Monitor, HEM-9210T, Blood Pressure Measurement Accuracy Based on Auscultation
- ClinicalTrials.gov ID
- NCT03130686
- Acronym / sponsor ID
- HDV-TCD-150311
- Conditions
- Blood Pressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Omron Healthcare Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Biwako Chuo Hospital Japan, Shared Care Research and Education Consulting,. Inc. US
- Study start
- 21 Dec 2015 (actual)
- Primary completion
- 18 Feb 2016 (actual)
- Study completion
- 31 Mar 2016 (actual)
- First posted
- 26 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to measure the blood pressure level of the patients, using a cuff ranged 17 - 50 cm.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Resident of a community
Key inclusion criteria (1 listed)
- Upper arm circumference: 17-50cm
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OMRON blood pressure monitor HEM-9210TTo measure systolic blood pressure, diastolic blood pressure and pulse rate in patients. | Device | – |
Primary outcome
Verify the accuracy of measure functions of device
Time frame: 30 days
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2017.
- Individual participant dataSharing planned: No. No plan to share the data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Pressure, run by Omron Healthcare Co., Ltd. at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Verify the accuracy of measure functions of device (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2017.