Efficacy of Wrist BPM MeasurementWristBPM01NCT01662947
Clinical Study of Wrist Blood Pressure Monitor in Conformance With the ANSI/AAMI SP10 Standard
A study testing Blood pressure Transtek Wrist Blood Pressure Monitor, TMB-1117 and Blood pressure Reference Device: Yuyue Medical Blood Pressure Meter, YYBP-2 in people with Efficacy of Wrist BPM Measurement and Hypertension, run by Leo Wang at 1 site in China.
Trial summary
The clinical protocol of the clinical testing of this device: 1. Objective of the test: To verify the efficiency of device. 2. Test methods and procedures: Clinical test in two positions: Seated and Supine. 3. DUT: Transtek Wrist Blood Pressure Monitor, Model: TMB-1117. Cuff size: 13.5 - 21.5 cm. 4. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Efficacy of Wrist BPM Measurement, Hypertension
- What is being tested?
- Blood pressure Transtek Wrist Blood Pressure Monitor, TMB-1117 and Blood pressure Reference Device: Yuyue Medical Blood Pressure Meter, YYBP-2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteChina
- Study dates
- May 2012to Jun 2012
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- male,female,
Who cannot join
- below 18 years old
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Verify Wrist BPM TMB-1117 to Comply With ANSI/AAMI SP10
The clinical protocol of the clinical testing of this device:
- Objective of the test: To verify the efficiency of device.
- Test methods and procedures: Clinical test in two positions: Seated and Supine.
- DUT: Transtek Wrist Blood Pressure Monitor, Model: TMB-1117. Cuff size: 13.5 - 21.5 cm.
- Comparison device: Yuyue Medical Blood Pressure Meter, YYBP-212, accuracy: ±1 mmHg and range: 0-300 mmHg.
- Study endpoints: Comply with ANSI/AAMI SP10-2002 standard.
- Statistical methodology used: Description of statistical methods.
- Result: Meet the requirements of SP10.
Read the detailed description
Hospital Information
Hospital Information The data was collected by Zhongshan City People's Hospital Clinical Investigator Team at Zhongshan City People's Hospital, No.2 Sunwen Dong Road, Zhongshan, Guangdong 528403, P. R. China.
Investigator: Dr. Cao Yuedong, Leader; Li Qidong, Nurse A; Chen Wenqian, Nurse B.
Contact Dr. Cao Yuedong Tel: +86 760 88823818
Used Equipments DUT (Device Under Test): Transtek Wrist Blood Pressure Monitor, TMB-1117 Reference Device: Yuyue Medical Blood Pressure Meter, YYBP-212, accuracy: ±1 mmHg and range: 0-300 mmHg.
Test Protocol
- Test Purpose: The aim of clinical test is to determine, for the purpose of design qualification, the overall performance of the system meeting the following requirement: For systolic and diastolic pressures, treated separately, the mean difference of the paired measurement of the test system and the comparison system shall be ± 5 mmHg or less, with standard deviation of 8 mmHg or less.
- Target Subject:
- The subject database shall contain at least 85 subjects. 2) The distribution of blood pressure of the subjects required to be: At least 10 percent below 100 mmHg systolic; at least 10 percent above 160 mmHg systolic; at least 10 percent below 60 mmHg diastolic; at least 10 percent above 100 mmHg diastolic; with the remainder distributed between these outer limits.
- Identification and precision of equipment used According to ANSI/AAMI SP10, the maximum measurement error of the non-automatic sphygmomanometers used in the comparing test shall not exceed 1.0mmHg at the temperature of the test. The manometer was used to verify its accuracy before test.
The clinical study was conducted according to the protocol described in the ANSI/AAMI SP10 with 85 subjects.
- Test procedures (auscultatory method, same-limb sequential measurement was chosen)
- Record the age, gender, and circumference of the left wrist of the subject.
- Let subject seated or supine calmly for five minutes before test.
- Measure heart rate in one minute by palpation on radial artery, record it.
- Two observers shall make simultaneous, blinded, blood pressure determination on the subject's left arm. Each nurse will write down the reading on a small piece of paper, make a tick if there is an auscultatory gap and then submit to the recorder.
- The two readings separately from two observers will be recorded, and if two observers agree that they find an auscultatory gap this time, it will also be recorded. The wrist cuff will be take off, after 90 seconds rest, TMB-1117 cuff will be taken on and tested, and the readings (systolic, diastolic, mean BP and Heart rate) be recorded.
- For each subject, repeat 3) and 5) to get 3 measurements.
- Repeat step 1) to 6) for every subject.
- Note:
- No motion and speaking are allowed during the measurement.
- The reference device's cuff release at the rate about 3 mmHg/s so to ensure an accurate reading of observer.
- The arm, wrist and the haear of subject to keep on the same height when measurement.
- Test environment: Temperature: 20±1 ℃; Relative humidity: 40~50%.
- Conditions
- Efficacy of Wrist BPM Measurement, Hypertension
- Being tested
- Blood pressure Transtek Wrist Blood Pressure Monitor, TMB-1117, Blood pressure Reference Device: Yuyue Medical Blood Pressure Meter, YYBP-2
- Keywords
- blood pressure
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood pressure Transtek Wrist Blood Pressure Monitor, TMB-1117Device
Also called DUT TMB-1117 measurement
Systolic, Diastolic pressure.
Blood pressure Reference Device: Yuyue Medical Blood Pressure Meter, YYBP-2Device
Also called Reference mercury sphygmomanometer measurement
Systolic, Diastolic pressure
| Study group | Role | What they receive |
|---|---|---|
| DUT Arm | Experimental | DUT: Transtek Wrist Blood Pressure Monitor TMB-1117
Measurement: Blood Pressure
Groups/Cohorts: DUT Receives: Device: Blood pressure Transtek Wrist Blood Pressure Monitor, TMB-1117 |
| Reference Arm | Experimental | Reference Device: Yuyue Medical Blood Pressure Meter, YYBP-212, accuracy: ±1mmHg and range: 0-300mmHg.
Measurement: Blood Pressure
Groups/Cohorts: Reference Receives: Device: Blood pressure Reference Device: Yuyue Medical Blood Pressure Meter, YYBP-2 |
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
Verify the accuracy of device if meet the requirements of ANSI/AAMI SP10 when it measure Systolic \& Diastolic blood pressure.
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2012 (estimated)
- Study startMay 2012
- Primary completionJun 2012
- Study completionJun 2012
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 Efficacy of Wrist BPM MeasurementStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leo Wang
- Sponsor type
- University, hospital or other
- Collaborators
- BTS International
- Responsible party
- Sponsor-investigator, Leo Wang, BTS International
- Investigators
- Leo Wang, Leader, Study chair, BTS International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01662947
- Sponsor's protocol ID
- Wrist BPM TMB-1117
- Other IDs
- BTS-TRANS12001
- Acronym
- WristBPM01
- Status last verified
- Aug 2012
- First submitted
- 1 Aug 2012
- Last updated
- 13 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Alpert BS. Validation of the Tiba Medical Ambulo 2400 ambulatory blood pressure monitor to the ISO Standard and BHS protocol. Blood Press Monit. 2010 Oct;15(5):275-7. doi: 10.1097/MBP.0b013e32833c8b39.
PubMed 20559140
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Verify Wrist BPM TMB-1117 to Comply With ANSI/AAMI SP10
- ClinicalTrials.gov ID
- NCT01662947
- Acronym / sponsor ID
- WristBPM01 / Wrist BPM TMB-1117
- Conditions
- Efficacy of Wrist BPM Measurement, Hypertension
- Keywords
- blood pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Leo WangUniversity, hospital or other
- Collaborators
- BTS International
- Study start
- May 2012
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 13 Aug 2012 (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 clinical protocol of the clinical testing of this device:
- Objective of the test: To verify the efficiency of device.
- Test methods and procedures: Clinical test in two positions: Seated and Supine.
- DUT: Transtek Wrist Blood Pressure Monitor, Model: TMB-1117. Cuff size: 13.5 - 21.5 cm.
- Comparison device: Yuyue Medical Blood Pressure Meter, YYBP-212, accuracy: ±1 mmHg and range: 0-300 mmHg.
- Study endpoints: Comply with ANSI/AAMI SP10-2002 standard.
- Statistical methodology used: Description of statistical methods.
- Result: Meet the requirements of SP10.
Detailed description
Hospital Information
Hospital Information The data was collected by Zhongshan City People's Hospital Clinical Investigator Team at Zhongshan City People's Hospital, No.2 Sunwen Dong Road, Zhongshan, Guangdong 528403, P. R. China.
Investigator: Dr. Cao Yuedong, Leader; Li Qidong, Nurse A; Chen Wenqian, Nurse B.
Contact Dr. Cao Yuedong Tel: +86 760 88823818
Used Equipments DUT (Device Under Test): Transtek Wrist Blood Pressure Monitor, TMB-1117 Reference Device: Yuyue Medical Blood Pressure Meter, YYBP-212, accuracy: ±1 mmHg and range: 0-300 mmHg.
Test Protocol
- Test Purpose: The aim of clinical test is to determine, for the purpose of design qualification, the overall performance of the system meeting the following requirement: For systolic and diastolic pressures, treated separately, the mean difference of the paired measurement of the test system and the comparison system shall be ± 5 mmHg or less, with standard deviation of 8 mmHg or less.
- Target Subject:
- The subject database shall contain at least 85 subjects. 2) The distribution of blood pressure of the subjects required to be: At least 10 percent below 100 mmHg systolic; at least 10 percent above 160 mmHg systolic; at least 10 percent below 60 mmHg diastolic; at least 10 percent above 100 mmHg diastolic; with the remainder distributed between these outer limits.
- Identification and precision of equipment used According to ANSI/AAMI SP10, the maximum measurement error of the non-automatic sphygmomanometers used in the comparing test shall not exceed 1.0mmHg at the temperature of the test. The manometer was used to verify its accuracy before test.
The clinical study was conducted according to the protocol described in the ANSI/AAMI SP10 with 85 subjects.
- Test procedures (auscultatory method, same-limb sequential measurement was chosen)
- Record the age, gender, and circumference of the left wrist of the subject.
- Let subject seated or supine calmly for five minutes before test.
- Measure heart rate in one minute by palpation on radial artery, record it.
- Two observers shall make simultaneous, blinded, blood pressure determination on the subject's left arm. Each nurse will write down the reading on a small piece of paper, make a tick if there is an auscultatory gap and then submit to the recorder.
- The two readings separately from two observers will be recorded, and if two observers agree that they find an auscultatory gap this time, it will also be recorded. The wrist cuff will be take off, after 90 seconds rest, TMB-1117 cuff will be taken on and tested, and the readings (systolic, diastolic, mean BP and Heart rate) be recorded.
- For each subject, repeat 3) and 5) to get 3 measurements.
- Repeat step 1) to 6) for every subject.
- Note:
- No motion and speaking are allowed during the measurement.
- The reference device's cuff release at the rate about 3 mmHg/s so to ensure an accurate reading of observer.
- The arm, wrist and the haear of subject to keep on the same height when measurement.
- Test environment: Temperature: 20±1 ℃; Relative humidity: 40~50%.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DUT Arm | Experimental | Device: Blood pressure Transtek Wrist Blood Pressure Monitor, TMB-1117DUT: Transtek Wrist Blood Pressure Monitor TMB-1117 Measurement: Blood Pressure Groups/Cohorts: DUT |
| Reference Arm | Experimental | Device: Blood pressure Reference Device: Yuyue Medical Blood Pressure Meter, YYBP-2Reference Device: Yuyue Medical Blood Pressure Meter, YYBP-212, accuracy: ±1mmHg and range: 0-300mmHg. Measurement: Blood Pressure Groups/Cohorts: Reference |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- male,female,
Key exclusion criteria (1 listed)
- below 18 years old
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 Transtek Wrist Blood Pressure Monitor, TMB-1117Also: DUT TMB-1117 measurementSystolic, Diastolic pressure. | Device | DUT Arm |
| Blood pressure Reference Device: Yuyue Medical Blood Pressure Meter, YYBP-2Also: Reference mercury sphygmomanometer measurementSystolic, Diastolic pressure | Device | Reference Arm |
Primary outcome
Verify the accuracy of measure functions of device
Time frame: 10 days
Verify the accuracy of device if meet the requirements of ANSI/AAMI SP10 when it measure Systolic \& Diastolic blood pressure.
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 13 Aug 2012.
- Background: PubMed 20559140Alpert BS. Validation of the Tiba Medical Ambulo 2400 ambulatory blood pressure monitor to the ISO Standard and BHS protocol. Blood Press Monit. 2010 Oct;15(5):275-7. doi: 10.1097/MBP.0b013e32833c8b39.
- Related InfoLink provided by the sponsor.
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.
Leo Wang, Leader study chair
BTS International
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 Transtek Wrist Blood Pressure Monitor, TMB-1117 and Blood pressure Reference Device: Yuyue Medical Blood Pressure Meter, YYBP-2 in people with Efficacy of Wrist BPM Measurement and Hypertension, run by Leo Wang 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 13 Aug 2012. 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?
Verify the accuracy of measure functions of device (time frame: 10 days). 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 NCT01662947, 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 13 Aug 2012.