Blood PressureNCT05551845
Blood Pressure Monitor Clinical Test (Cuff Range: 15-24,20-34,30-44,22-42）
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 verify the accuracy of the 4 blood pressure cuffs with blood pressure monitor device. Cuff circumference is : 15cm-24cm, 20cm-34cm, 30cm-44cm, 22cm-42cm Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 7 Apr 2021to 1 Mar 2022
- 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 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Normal blood pressure and hypertensive patients over 12 years old
Who may be able to join
- Normal blood pressure and hypertensive patients over 12 years old
Who cannot join
- Patients with serious arrhythmias or a high frequency of arrhythmias
- pregnant woman
- Other investigators believe that it is not suitable to participate in this clinical trial
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Tianjin
About this study
Official title: Blood Pressure Monitor（Model：KD-595） Clinical Test
The purpose of this study is to verify the accuracy of the 4 blood pressure cuffs with blood pressure monitor device.
Cuff circumference is : 15cm-24cm, 20cm-34cm, 30cm-44cm, 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 |
|---|---|---|
| Subject use both KD-595 Arm Automatic Electronic BPM and mercury sphygmomanometers | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood pressure monitor accuracy
All the test results of the electronic blood pressure monitor with 4 cuffs is within the accuracy creteria, with the merury sphygmomanometer as control
Measured: 30minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2022
- Study start7 Apr 2021
- Primary completion30 Jun 2021
- Study completion1 Mar 2022
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
- Other
- Time perspective
- Prospective
- Enrolment
- 90 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
- NCT05551845
- Sponsor's protocol ID
- Andon Health 10
- Status last verified
- Oct 2022
- First submitted
- 20 Sep 2022
- Last updated
- 28 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Pressure Monitor（Model：KD-595） Clinical Test
- ClinicalTrials.gov ID
- NCT05551845
- Acronym / sponsor ID
- Andon Health 10
- Conditions
- Blood Pressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Andon Health Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 7 Apr 2021 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 23 Sep 2022 (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 verify the accuracy of the 4 blood pressure cuffs with blood pressure monitor device.
Cuff circumference is : 15cm-24cm, 20cm-34cm, 30cm-44cm, 22cm-42cm
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subject use both KD-595 Arm Automatic Electronic BPM and mercury sphygmomanometers | – | – |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Normal blood pressure and hypertensive patients over 12 years old
Key inclusion criteria (1 listed)
- Normal blood pressure and hypertensive patients over 12 years old
Key exclusion criteria (3 listed)
- Patients with serious arrhythmias or a high frequency of arrhythmias
- pregnant woman
- Other investigators believe that it is not suitable to participate in this clinical trial
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
blood pressure monitor accuracy
Time frame: 30minutes
All the test results of the electronic blood pressure monitor with 4 cuffs is within the accuracy creteria, with the merury sphygmomanometer as control
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 28 Jul 2023.
- Individual participant dataSharing planned: No
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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 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 3 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 28 Jul 2023. 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?
blood pressure monitor accuracy (time frame: 30minutes). 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 28 Jul 2023.