Blood PressureNCT06573216
Clinical Trial of Wrist Ambulatory Blood Pressure Monitor in Conformance With the EN ISO 81060-2:2018+AMD1:2020
A study testing Wrist Ambulatory Blood Pressure Monitor in people with Blood Pressure, run by Huawei Device Co., Ltd at 1 site in China.
Trial summary
The accuracy and safety of the Wrist Ambulatory Blood Pressure Recorder (Model: LCA-B10) were assessed according to the requirements of EN ISO 81060-2:2018 + AMD1:2020. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure
- What is being tested?
- Wrist Ambulatory Blood Pressure Monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteChina
- Study dates
- 24 Apr 2024to 4 Jun 2024
- 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
- Subjects should voluntarily participate in the clinical trial and sign the informed consent form;
- Subjects must be willing and able to follow the study procedures;
- Subjects are over 18 years old whose wrist circumference should be within 13.0-21.0cm.
Who cannot join
- Subjects with serious arrhythmias (atrial fibrillation, atrial flutter, ventricular flutter, ventricular fibrillation, ventricular tachycardia, borderline tachycardia, sinus arrest, pathological sinus syndrome, pacemaker rhythm) showed by electrocardiogram during screening period;
- Subjects with sickle cell disease;
- Subjects with prior mastectomy or arm lymph node dissection;
- Subjects who are allergic to nylon, fluororubber or thermo-plastic polyurethane elastomer (TPU);
- Subjects with wounds on the limb at the measurement site or inflammation of the wrist
- Subjects who are undergoing intravenous fluid therapy, blood transfusion or other catheterization at the measurement site limb;
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- Subjects who have eaten, consumed alcohol, smoked cigarettes, or exercised vigorously 30 minutes prior to the trial;
- Subjects who have participated in other clinical trials within 30 days that may affect this trial;
- Subjects who, in the opinion of the investigator, should not participate in this clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Trial on the Effectiveness and Safety of Blood Pressure Function System of Wrist Ambulatory Blood Pressure Monitor
The accuracy and safety of the Wrist Ambulatory Blood Pressure Recorder (Model: LCA-B10) were assessed according to the requirements of EN ISO 81060-2:2018 + AMD1:2020.
- Conditions
- Blood Pressure
- Being tested
- Wrist Ambulatory Blood Pressure Monitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wrist Ambulatory Blood Pressure MonitorDevice
Comparing blood pressure measured by wrist blood pressure monitor with mercury sphygmomanometer .
| Study group | Role | What they receive |
|---|---|---|
| Blood pressure measured by wrist ambulatory blood pressure monitor and mercury sphygmomanometer | Experimental | Not described Receives: Device: Wrist Ambulatory Blood Pressure Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure mean deviation and standard deviation- evaluation criterion 1
The mean deviation and standard deviation between the blood pressure values measured by the investigational device and those obtained using the auscultatory method with the reference device. This calculation is performed on valid data pairsof subjects (n≥255).
Evaluation criterion 1: The blood pressure mean deviation should not exceed ±5mmHg, and the standard deviation should not exceed 8mmHg.
Measured: 30 minutes
Blood pressure mean deviation and standard deviation- evaluation criterion 2
The mean deviation and standard deviation between the blood pressure values measured by the investigational device and those obtained using the auscultatory method with the reference device. This calculation is performed on the valid data group of all subjects (m≥85).
Evaluation criterion 2: The blood pressure standard deviation within the valid data group (m ≥ 85) should not exceed the maximum allowable standard deviation corresponding to the mean deviation listed in Criterion 2 in section 5.2.4.1.2 b of ISO 81060-2:2018+AMD1:2020.
Measured: 30 minutes
The mean deviation and standard deviation of blood pressure measurements under ambulatory blood pressure monitoring
The mean deviation and standard deviation of the blood pressure within the valid data group are calculated to evaluate whether the clinical accuracy of the investigational device meets the requirements outlined in ISO 81060-2:2018+AMD1:2020, specifically in section 5.2.4.1.2a).
The blood pressure mean deviation should not exceed ±5mmHg, and the standard deviation should not exceed 8mmHg.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2024
- Study start24 Apr 2024
- Primary completion4 Jun 2024
- Study completion4 Jun 2024
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huawei Device Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06573216
- Sponsor's protocol ID
- CTP-PPA0971CHN24011810332987
- Status last verified
- Aug 2024
- First submitted
- 26 Aug 2024
- Last updated
- 27 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial on the Effectiveness and Safety of Blood Pressure Function System of Wrist Ambulatory Blood Pressure Monitor
- ClinicalTrials.gov ID
- NCT06573216
- Acronym / sponsor ID
- CTP-PPA0971CHN24011810332987
- Conditions
- Blood Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Huawei Device Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 24 Apr 2024 (actual)
- Primary completion
- 4 Jun 2024 (actual)
- Study completion
- 4 Jun 2024 (actual)
- First posted
- 27 Aug 2024 (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 the Wrist Ambulatory Blood Pressure Recorder (Model: LCA-B10) were assessed according to the requirements of EN ISO 81060-2:2018 + AMD1:2020.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blood pressure measured by wrist ambulatory blood pressure monitor and mercury sphygmomanometer | Experimental | Device: Wrist Ambulatory Blood Pressure Monitor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects should voluntarily participate in the clinical trial and sign the informed consent form;
- Subjects must be willing and able to follow the study procedures;
- Subjects are over 18 years old whose wrist circumference should be within 13.0-21.0cm.
Key exclusion criteria (9 listed)
- Subjects with serious arrhythmias (atrial fibrillation, atrial flutter, ventricular flutter, ventricular fibrillation, ventricular tachycardia, borderline tachycardia, sinus arrest, pathological sinus syndrome, pacemaker rhythm) showed by electrocardiogram during screening period;
- Subjects with sickle cell disease;
- Subjects with prior mastectomy or arm lymph node dissection;
- Subjects who are allergic to nylon, fluororubber or thermo-plastic polyurethane elastomer (TPU);
- Subjects with wounds on the limb at the measurement site or inflammation of the wrist
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 |
|---|---|---|
| Wrist Ambulatory Blood Pressure MonitorComparing blood pressure measured by wrist blood pressure monitor with mercury sphygmomanometer . | Device | Blood pressure measured by wrist ambulatory blood pressure monitor and mercury sphygmomanometer |
Primary outcome
Blood pressure mean deviation and standard deviation- evaluation criterion 1
Time frame: 30 minutes
The mean deviation and standard deviation between the blood pressure values measured by the investigational device and those obtained using the auscultatory method with the reference device. This calculation is performed on valid data pairsof subjects (n≥255). Evaluation criterion 1: The blood pressure mean deviation should not exceed ±5mmHg, and the standard deviation should not exceed 8mmHg.
Blood pressure mean deviation and standard deviation- evaluation criterion 2
Time frame: 30 minutes
The mean deviation and standard deviation between the blood pressure values measured by the investigational device and those obtained using the auscultatory method with the reference device. This calculation is performed on the valid data group of all subjects (m≥85). Evaluation criterion 2: The blood pressure standard deviation within the valid data group (m ≥ 85) should not exceed the maximum allowable standard deviation corresponding to the mean deviation listed in Criterion 2 in section 5.2.4.1.2 b of ISO 81060-2:2018+AMD1:2020.
The mean deviation and standard deviation of blood pressure measurements under ambulatory blood pressure monitoring
Time frame: 30 minutes
The mean deviation and standard deviation of the blood pressure within the valid data group are calculated to evaluate whether the clinical accuracy of the investigational device meets the requirements outlined in ISO 81060-2:2018+AMD1:2020, specifically in section 5.2.4.1.2a). The blood pressure mean deviation should not exceed ±5mmHg, and the standard deviation should not exceed 8mmHg.
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 Aug 2024.
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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 Wrist Ambulatory Blood Pressure Monitor in people with Blood Pressure, run by Huawei Device 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 3 inclusion and 9 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 Aug 2024. 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 mean deviation and standard deviation- evaluation criterion 1 (time frame: 30 minutes). The study lists 3 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 27 Aug 2024.