Blood PressureNCT02021994
BPM Cuff： 15-24cm, 20-34cm, 30-44cm, 40-48cm, 22-42cm
An observational study of Blood Pressure, run by Andon Health Co., Ltd.
Trial summary
The purpose of this study is to verify the accuracy of the 5 blood pressure cuffs, with blood pressure monitor device. The cuff range is as follows: 15cm-24cm, 20cm-34cm, 30cm-44cm, 40cm-48cm, and 22cm-42cm Read more about this study
- Who is it for?
- Ages 20 to 83 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure
- How many people
- 85 participants
- Where
- No sites listed yet
- Study dates
- Jun 2013to Sep 2013
- 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 20 to 83 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: resident of a community
Who may be able to join
- Normal adult or adults with Hypertension
Who cannot join
- ⎯1) people with serious arrhythmia
- Patients with Takayasu arteritis
- people wit adverse vascular peripheral circulation
- people with upper limbs vein thrombosis
- people who is weak
About this study
The purpose of this study is to verify the accuracy of the 5 blood pressure cuffs, with blood pressure monitor device.
The cuff range is as follows:
15cm-24cm, 20cm-34cm, 30cm-44cm, 40cm-48cm, and 22cm-42cm
- Conditions
- Blood Pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Arm Automatic Electronic BPM | Not described | |
| mercury sphygmomanometer | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
All the test results of the electronic blood pressure monitor with 5 cuffs is within the accuracy creteria, with the mercury sphygmomanometer as control
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2013 (estimated)
- Study startJun 2013
- Primary completionSep 2013
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
- Time perspective
- Prospective
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andon Health Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02021994
- Sponsor's protocol ID
- Andon Health 9
- Status last verified
- Dec 2013
- First submitted
- 10 Sep 2013
- Last updated
- 27 Dec 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BPM Cuff： 15-24cm, 20-34cm, 30-44cm, 40-48cm, 22-42cm
- ClinicalTrials.gov ID
- NCT02021994
- Acronym / sponsor ID
- Andon Health 9
- Conditions
- Blood Pressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Andon Health Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Sep 2013 (actual)
- First posted
- 27 Dec 2013 (estimated)
- 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 verify the accuracy of the 5 blood pressure cuffs, with blood pressure monitor device.
The cuff range is as follows:
15cm-24cm, 20cm-34cm, 30cm-44cm, 40cm-48cm, and 22cm-42cm
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm Automatic Electronic BPM | – | – |
| mercury sphygmomanometer | – | – |
Who may qualify
- Ages
- 20 to 83 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- resident of a community
Key inclusion criteria (1 listed)
- Normal adult or adults with Hypertension
Key exclusion criteria (5 listed)
- ⎯1) people with serious arrhythmia
- Patients with Takayasu arteritis
- people wit adverse vascular peripheral circulation
- people with upper limbs vein thrombosis
- people who is weak
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
All the test results of the electronic blood pressure monitor with 5 cuffs is within the accuracy creteria, with the mercury sphygmomanometer as control
Time frame: 1 day
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 27 Dec 2013.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Pressure, run by Andon Health Co., Ltd.
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 5 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 27 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
All the test results of the electronic blood pressure monitor with 5 cuffs is within the accuracy creteria, with the mercury sphygmomanometer as control (time frame: 1 day). 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 27 Dec 2013.