Blood PressureNCT03382691
Accuracy of a Blood Pressure Measuring Mobile Device in Volunteers
A study testing blood pressure check in people with Blood Pressure, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The accuracy and safety of blood pressure module of new mobile device (M- HEALTHCARE device) is evaluated according to Korean FDA guidelines in 100 healthy volunteers. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure
- What is being tested?
- blood pressure check
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2016to Jan 2017
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants whose systolic blood pressure <=110 should be at least 10% of whole cohort
- Participants whose systolic blood pressure >=160 should be at least 10% of whole cohort
- Participants whose diastolic blood pressure >=100 should be at least 10% of whole cohort
- Participants whose diastolic blood pressure <=70 should be at least 10% of whole cohort
- Participants whose arm circumference are between 20cm and 30cm should be 25 - 50% of whole cohort
- Participants whose arm circumference are between 30cm and 40cm should be 50 - 75% of whole cohort
Who cannot join
- heart disease with abnormal rhythm
- peripheral vascular anomaly or disease
- inadequate to be applied blood pressure cuff (e.g. trauma on arm)
- pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyenggi DO, 463707
About this study
Official title: M- HEALTHCARE Confirmatory Clinical Trials Used for Measurement of the ABP for the Accuracy and Safety Assessment of the Module Measuring Blood Pressure
The accuracy and safety of blood pressure module of new mobile device (M- HEALTHCARE device) is evaluated according to Korean FDA guidelines in 100 healthy volunteers.
- Conditions
- Blood Pressure
- Being tested
- blood pressure check
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood pressure checkDevice
Check blood pressure using new device and conventional device alternatively. Compare blood pressure measured with new device and conventional device.
| Study group | Role | What they receive |
|---|---|---|
| EXPERIMENTAL | Experimental | Blood pressure check using mobile device and control device Receives: Device: blood pressure check |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean difference of systolic blood pressure
mean difference of blood pressure between new and control device
Measured: 1 day at visit 2
mean difference of diastolic blood pressure
mean difference of diastolic blood pressure between new and control device
Measured: 1 day at visit 2
standard deviation of the difference of systolic blood pressure
standard deviation of the difference of systolic blood pressure between new and control device
Measured: 1 day at visit 2
standard deviation of the difference of diastolic blood pressure
standard deviation of the difference of diastolic blood pressure between new and control device
Measured: 1 day at visit 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2017
- Study startDec 2016
- Primary completionJan 2017
- Study completionJan 2017
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.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Seoul National University Bundang Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03382691
- Sponsor's protocol ID
- SNUBH_GO_056
- Status last verified
- Oct 2017
- First submitted
- 29 Oct 2017
- Last updated
- 26 Dec 2017
- Results posted
- No
- Data monitoring committee
- 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 26 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- M- HEALTHCARE Confirmatory Clinical Trials Used for Measurement of the ABP for the Accuracy and Safety Assessment of the Module Measuring Blood Pressure
- ClinicalTrials.gov ID
- NCT03382691
- Acronym / sponsor ID
- SNUBH_GO_056
- Conditions
- Blood Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Seoul National University Bundang Hospital
- Study start
- Dec 2016 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 26 Dec 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 accuracy and safety of blood pressure module of new mobile device (M- HEALTHCARE device) is evaluated according to Korean FDA guidelines in 100 healthy volunteers.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EXPERIMENTAL | Experimental | Device: blood pressure checkBlood pressure check using mobile device and control device |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participants whose systolic blood pressure <=110 should be at least 10% of whole cohort
- Participants whose systolic blood pressure >=160 should be at least 10% of whole cohort
- Participants whose diastolic blood pressure >=100 should be at least 10% of whole cohort
- Participants whose diastolic blood pressure <=70 should be at least 10% of whole cohort
- Participants whose arm circumference are between 20cm and 30cm should be 25 - 50% of whole cohort
Key exclusion criteria (4 listed)
- heart disease with abnormal rhythm
- peripheral vascular anomaly or disease
- inadequate to be applied blood pressure cuff (e.g. trauma on arm)
- pregnant or lactating women
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 |
|---|---|---|
| blood pressure checkCheck blood pressure using new device and conventional device alternatively. Compare blood pressure measured with new device and conventional device. | Device | EXPERIMENTAL |
Primary outcome
mean difference of systolic blood pressure
Time frame: 1 day at visit 2
mean difference of blood pressure between new and control device
mean difference of diastolic blood pressure
Time frame: 1 day at visit 2
mean difference of diastolic blood pressure between new and control device
standard deviation of the difference of systolic blood pressure
Time frame: 1 day at visit 2
standard deviation of the difference of systolic blood pressure between new and control device
standard deviation of the difference of diastolic blood pressure
Time frame: 1 day at visit 2
standard deviation of the difference of diastolic blood pressure between new and control device
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 Dec 2017.
- 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?
A study testing blood pressure check in people with Blood Pressure, run by Seoul National University Hospital at 1 site in South Korea.
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 6 inclusion and 4 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 Dec 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 South Korea. 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?
mean difference of systolic blood pressure (time frame: 1 day at visit 2). The study lists 4 primary outcomes in all. 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 Dec 2017.