Blood PressureWBPMCTNCT00952965
Wrist-used Blood Pressure Monitor Clinical Test (Cuff Range: 14cm-25cm)
An observational study of Blood Pressure, run by Andon Health Co., Ltd at 1 site in China.
Trial summary
The purpose of this study is to monitor the blood pressure level of the patient using a wrist cuff ranged 14 cm-25 cm. Read more about this study
- Who is it for?
- Ages 23 to 81 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure
- How many people
- 86 participants
- Where
- 1 siteChina
- Study dates
- Apr 2009to Jul 2009
- 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 23 to 81 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: resident of a community.
Who may be able to join
- wrist circumference: 14 cm-25 cm
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Testing Report for Wrist-used Electronic Blood Pressure Monitor
The purpose of this study is to monitor the blood pressure level of the patient using a wrist cuff ranged 14 cm-25 cm.
- Conditions
- Blood Pressure
- Keywords
- BP
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 |
|---|---|---|
| blood pressure monitor | wrist circumference: 14cm-25cm | |
| stethoscopy | wrist circumference: 14cm-25cm |
What is being measured
The primary outcome is the main question the study is designed to answer.
level of blood pressure
Measured: 10 s
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2009 (estimated)
- Study startApr 2009
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andon Health Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Qi Sun, Principal investigator, Andon Health Co., Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00952965
- Sponsor's protocol ID
- AndonHealth2
- Acronym
- WBPMCT
- Status last verified
- Aug 2009
- First submitted
- 5 Aug 2009
- Last updated
- 6 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Wong SN, Tz Sung RY, Leung LC. Validation of three oscillometric blood pressure devices against auscultatory mercury sphygmomanometer in children. Blood Press Monit. 2006 Oct;11(5):281-91. doi: 10.1097/01.mbp.0000209082.09623.b4.
PubMed 16932037
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Testing Report for Wrist-used Electronic Blood Pressure Monitor
- ClinicalTrials.gov ID
- NCT00952965
- Acronym / sponsor ID
- WBPMCT / AndonHealth2
- Conditions
- Blood Pressure
- Keywords
- BP
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Andon Health Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 6 Aug 2009 (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 monitor the blood pressure level of the patient using a wrist cuff ranged 14 cm-25 cm.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| blood pressure monitor | – | –wrist circumference: 14cm-25cm |
| stethoscopy | – | –wrist circumference: 14cm-25cm |
Who may qualify
- Ages
- 23 to 81 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- resident of a community.
Key inclusion criteria (1 listed)
- wrist circumference: 14 cm-25 cm
Key exclusion criteria (1 listed)
- none
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
level of blood pressure
Time frame: 10 s
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 6 Aug 2009.
- Background: PubMed 16932037Wong SN, Tz Sung RY, Leung LC. Validation of three oscillometric blood pressure devices against auscultatory mercury sphygmomanometer in children. Blood Press Monit. 2006 Oct;11(5):281-91. doi: 10.1097/01.mbp.0000209082.09623.b4.
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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.
Qi Sun principal investigator
Andon Health Co., Ltd
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 Andon Health Co., Ltd at 1 site in China.
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 1 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 6 Aug 2009. 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 China. 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?
level of blood pressure (time frame: 10 s). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00952965, which also lists 1 linked publication.
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 6 Aug 2009.