Blood PressureNCT06457568
Validation Study of CONTEC08C Electronic Sphygmomanometer
A study testing Blood pressure measurement in people with Blood Pressure, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.
Trial summary
The purpose of this study is to assess the accuracy of the CONTEC08C automated oscillometric upper-arm sphygmomanometer in the general population for clinical use according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension /International Organization for Standardization… Read more about this study
- Who is it for?
- Ages 12 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure
- What is being tested?
- Blood pressure measurement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 25 May 2024to 1 Aug 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 12 to 79 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Subjects aged 12 to 79 years
- Subjects voluntarily participate in the clinical trial and sign the informed consent.
Who cannot join
- Subjects with cardiac arrhythmias;
- Pregnancy;
- Poor quality Korotkoff sounds;
- Subject with an arm injury incompatible with the use of a cuff-based sphygmomanometer;
- Other conditions that the investigator considers ineligible for clinical trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Chinese Academy of Medical Sciences，Fuwai Hospital
Beijing, Beijing Municipality, 100037
Ying Lou, MD
About this study
Official title: Validation of the CONTEC08C Oscillometric Blood Pressure Monitor in General Population According to the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018)
The purpose of this study is to assess the accuracy of the CONTEC08C automated oscillometric upper-arm sphygmomanometer in the general population for clinical use according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension /International Organization for Standardization (AAMI/ESH/ISO) Universal Standard (ISO 81060-2:2018).
- Conditions
- Blood Pressure
- Being tested
- Blood pressure measurement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood pressure measurementDiagnostic test
The blood pressure measurement was taken simultaneously by two observers using mercury sphygmomanometer and by a supervisor using the tested device, CONTEC08C.
| Study group | Role | What they receive |
|---|---|---|
| CONTEC08C and mercury sphygmomanometer | Experimental | Blood Pressure Measurement with the CONTEC08C Oscillometric Sphygmomanometer (CONTEC08C) and with Mercury Sphygmomanometer Receives: Diagnostic Test: Blood pressure measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure measurement data
Systolic Blood Pressure and Diastolic Blood Pressure
Measured: 30mintues
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start25 May 2024
- Primary completion25 Jul 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
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.
- More trials run by Chinese Academy of Medical Sciences, Fuwai 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 (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lou ying, Chinese Academy of Medical Sciences, Fuwai Hospital
- Investigators
- Ying Lou, MD, Principal investigator, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06457568
- Sponsor's protocol ID
- 2023-ZX082
- Status last verified
- Jun 2024
- First submitted
- 8 Jun 2024
- Last updated
- 24 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chen M, Wang W, Wang L, Bian J, Ma W, Bai J, Lou Y, Cai J. Validation of the CONTEC08C oscillometric blood pressure monitor in adults according to the International Organization for Standardization 81060-2:2018 standard. Blood Press Monit. 2026 Apr 1;31(2):86-89. doi: 10.1097/MBP.0000000000000781. Epub 2025 Nov 3.
PubMed 41186208
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the CONTEC08C Oscillometric Blood Pressure Monitor in General Population According to the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018)
- ClinicalTrials.gov ID
- NCT06457568
- Acronym / sponsor ID
- 2023-ZX082
- Conditions
- Blood Pressure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Study start
- 25 May 2024 (actual)
- Primary completion
- 25 Jul 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 13 Jun 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 purpose of this study is to assess the accuracy of the CONTEC08C automated oscillometric upper-arm sphygmomanometer in the general population for clinical use according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension /International Organization for Standardization (AAMI/ESH/ISO) Universal Standard (ISO 81060-2:2018).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CONTEC08C and mercury sphygmomanometer | Experimental | Diagnostic Test: Blood pressure measurementBlood Pressure Measurement with the CONTEC08C Oscillometric Sphygmomanometer (CONTEC08C) and with Mercury Sphygmomanometer |
Who may qualify
- Ages
- 12 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects aged 12 to 79 years
- Subjects voluntarily participate in the clinical trial and sign the informed consent.
Key exclusion criteria (5 listed)
- Subjects with cardiac arrhythmias;
- Pregnancy;
- Poor quality Korotkoff sounds;
- Subject with an arm injury incompatible with the use of a cuff-based sphygmomanometer;
- Other conditions that the investigator considers ineligible for 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood pressure measurementThe blood pressure measurement was taken simultaneously by two observers using mercury sphygmomanometer and by a supervisor using the tested device, CONTEC08C. | Diagnostic test | CONTEC08C and mercury sphygmomanometer |
Primary outcome
Blood pressure measurement data
Time frame: 30mintues
Systolic Blood Pressure and Diastolic Blood Pressure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2024.
- Derived from this study: PubMed 41186208Chen M, Wang W, Wang L, Bian J, Ma W, Bai J, Lou Y, Cai J. Validation of the CONTEC08C oscillometric blood pressure monitor in adults according to the International Organization for Standardization 81060-2:2018 standard. Blood Press Monit. 2026 Apr 1;31(2):86-89. doi: 10.1097/MBP.0000000000000781. Epub 2025 Nov 3.
- 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.
Ying Lou, MD principal investigator
Chinese Academy of Medical Sciences, Fuwai Hospital
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 measurement in people with Blood Pressure, run by Chinese Academy of Medical Sciences, Fuwai Hospital 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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 24 Jun 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ying Lou, MD (86(10)88392170, fuwailou1798@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure measurement data (time frame: 30mintues). 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 NCT06457568, 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 24 Jun 2024.