Blood PressureNCT06513975
Validation Study of CART BP as a Wearable Cuffless Blood Pressure Monitor
A study testing CART BP and sphygmomanometer in people with Blood Pressure and Hypertension, run by Sky Labs at 1 site in South Korea.
Trial summary
This study aims to evaluate the accuracy of the CART BP, a medically approved ring-type blood pressure monitor, in comparison to the traditional auscultatory method using a dual-head stethoscope. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure, Hypertension, Blood Pressure, High
- What is being tested?
- CART BP and sphygmomanometer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 Nov 2024to 15 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects aged 18 years or older but younger than 80 years
- Individuals who voluntarily decide to participate in this clinical trial and provide written consent to the information and consent form
- Individuals willing to comply with the clinical trial protocol
Who cannot join
- Subjects who do not consent to the study
- Obese individuals with a Body Mass Index (BMI) of 30 or higher (concerns about measurement errors as the standard 24-hour ambulatory blood pressure monitor cuff may not fit the arm properly)
- Patients or volunteers who are pregnant
- Patients or volunteers with underlying heart diseases: those with a history of hospitalization for heart failure, valvular disease, or myocardial infarction
- Patients or volunteers diagnosed with atrial fibrillation on a 12-lead electrocardiogram (ECG) within the past 6 months
- Patients or volunteers with end-stage renal disease (undergoing dialysis)
Show all 9Show fewer
- Patients or volunteers unable to perform repeated exercises required for the study
- Patients or volunteers with a systolic blood pressure (SBP) exceeding 160 millimeters of mercury (mmHg)
- Patients or volunteers with a systolic blood pressure (SBP) exceeding 160 millimeters of mercury (mmHg) and/or a diastolic blood pressure (DBP) exceeding 100 millimeters of mercury (mmHg) (for exercise tests)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul
Seung Woo Park
About this study
Official title: Validation Study of CART BP as a Wearable Cuffless Blood Pressure Monitor: Evaluation of Blood Pressure Measurement by Height and Physical Activity
This study aims to evaluate the accuracy of the CART BP, a medically approved ring-type blood pressure monitor, in comparison to the traditional auscultatory method using a dual-head stethoscope. The comparison is conducted in accordance with the 2023 European Society of Hypertension (ESH) Recommendations, focusing on patients with suspected hypertension or hypotension. The evaluation includes accuracy measurements across various postures and during different exercise periods.
Read the detailed description
There is a non-invasive technique called Photoplethysmography (PPG) that overcomes the limitations of traditional auscultatory and oscillometric methods. Photoplethysmography uses light-emitting diodes (LEDs) to illuminate human tissue, specifically targeting blood vessels, and employs sensors to measure the volume of blood flowing through the tissue. This technique can be applied to various parts of the small arterial system in the human body, enabling cuffless blood pressure measurement. As a result, it simplifies blood pressure monitoring for subjects and allows for extended observation periods.
With the advancement of cuffless blood pressure monitors, the European Society of Hypertension (ESH) has established recommendations to ensure accurate measurements. The recommendations consider variations in measurement height and compare accuracy after blood pressure is elevated through aerobic exercise or low-intensity repetitive exercises, such as handgrip exercises. This study aims to follow the 2023 European Society of Hypertension recommendations by measuring blood pressure with the arm positioned vertically more than 20 centimeters below the standard position and comparing the results obtained after repeated handgrip exercises with those obtained using the standard method.
- Being tested
- CART BP, sphygmomanometer
- Medical subject headings
- Hypertension, Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CART BPDevice
A ring-type medical device worn by the subject that non-invasively measures systolic and diastolic blood pressure, as well as pulse rate.
sphygmomanometerDevice
Blood pressure measurement method utilizing a two-headed stethoscope, allowing two observers to simultaneously hear the Korotkoff sounds.
| Study group | Role | What they receive |
|---|---|---|
| Subjects requiring 24-hour ambulatory blood pressure monitoring | Experimental | Subjects prescribed for ambulatory blood pressure monitor (ABPM) measure 24-hour blood pressure using both the CART BP and sphygmomanometer Receives: Device: CART BP; Device: sphygmomanometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean error and standard deviations of differences between CART BP and Reference
The primary outcome measure is the mean error and standard deviation (SD) of the differences between the CART BP device and the reference device. This endpoint is determined based on the European Hypertension Society (ESH) recommendation, which states that the pass criteria are as per International Organization for Standardization (ISO) 81060-2:2018: a mean error within 5 mmHg and an standard deviation within ±8 mmHg.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start22 Nov 2024
- Primary completion15 Aug 2025 (estimated)
- Study completion15 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sky Labs
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Samsung Medical Center
- Responsible party
- Sponsor
- Investigators
- Seung Woo Park, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06513975
- Sponsor's protocol ID
- SL_BP_V1.0
- Status last verified
- Jun 2025
- First submitted
- 16 Jul 2024
- Last updated
- 15 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Carey RM, Muntner P, Bosworth HB, Whelton PK. Prevention and Control of Hypertension: JACC Health Promotion Series. J Am Coll Cardiol. 2018 Sep 11;72(11):1278-1293. doi: 10.1016/j.jacc.2018.07.008.
PubMed 30190007Stergiou GS, Avolio AP, Palatini P, Kyriakoulis KG, Schutte AE, Mieke S, Kollias A, Parati G, Asmar R, Pantazis N, Stamoulopoulos A, Asayama K, Castiglioni P, De La Sierra A, Hahn JO, Kario K, McManus RJ, Myers M, Ohkubo T, Shroff SG, Tan I, Wang J, Zhang Y, Kreutz R, O'Brien E, Mukkamala R. European Society of Hypertension recommendations for the validation of cuffless blood pressure measuring devices: European Society of Hypertension Working Group on Blood Pressure Monitoring and Cardiovascular Variability. J Hypertens. 2023 Dec 1;41(12):2074-2087. doi: 10.1097/HJH.0000000000003483. Epub 2023 Jun 22.
PubMed 37303198Kario K, Shin J, Chen CH, Buranakitjaroen P, Chia YC, Divinagracia R, Nailes J, Hoshide S, Siddique S, Sison J, Soenarta AA, Sogunuru GP, Tay JC, Teo BW, Turana Y, Zhang Y, Park S, Van Minh H, Wang JG. Expert panel consensus recommendations for ambulatory blood pressure monitoring in Asia: The HOPE Asia Network. J Clin Hypertens (Greenwich). 2019 Sep;21(9):1250-1283. doi: 10.1111/jch.13652.
PubMed 31532913O'Brien E, Parati G, Stergiou G, Asmar R, Beilin L, Bilo G, Clement D, de la Sierra A, de Leeuw P, Dolan E, Fagard R, Graves J, Head GA, Imai Y, Kario K, Lurbe E, Mallion JM, Mancia G, Mengden T, Myers M, Ogedegbe G, Ohkubo T, Omboni S, Palatini P, Redon J, Ruilope LM, Shennan A, Staessen JA, vanMontfrans G, Verdecchia P, Waeber B, Wang J, Zanchetti A, Zhang Y; European Society of Hypertension Working Group on Blood Pressure Monitoring. European Society of Hypertension position paper on ambulatory blood pressure monitoring. J Hypertens. 2013 Sep;31(9):1731-68. doi: 10.1097/HJH.0b013e328363e964.
PubMed 24029863
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation Study of CART BP as a Wearable Cuffless Blood Pressure Monitor: Evaluation of Blood Pressure Measurement by Height and Physical Activity
- ClinicalTrials.gov ID
- NCT06513975
- Acronym / sponsor ID
- SL_BP_V1.0
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sky LabsIndustry (pharma, biotech, devices)
- Collaborators
- Samsung Medical Center
- Study start
- 22 Nov 2024 (actual)
- Primary completion
- 15 Aug 2025 (estimated)
- Study completion
- 15 Aug 2025 (estimated)
- First posted
- 23 Jul 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.
This study aims to evaluate the accuracy of the CART BP, a medically approved ring-type blood pressure monitor, in comparison to the traditional auscultatory method using a dual-head stethoscope. The comparison is conducted in accordance with the 2023 European Society of Hypertension (ESH) Recommendations, focusing on patients with suspected hypertension or hypotension. The evaluation includes accuracy measurements across various postures and during different exercise periods.
Detailed description
There is a non-invasive technique called Photoplethysmography (PPG) that overcomes the limitations of traditional auscultatory and oscillometric methods. Photoplethysmography uses light-emitting diodes (LEDs) to illuminate human tissue, specifically targeting blood vessels, and employs sensors to measure the volume of blood flowing through the tissue. This technique can be applied to various parts of the small arterial system in the human body, enabling cuffless blood pressure measurement. As a result, it simplifies blood pressure monitoring for subjects and allows for extended observation periods.
With the advancement of cuffless blood pressure monitors, the European Society of Hypertension (ESH) has established recommendations to ensure accurate measurements. The recommendations consider variations in measurement height and compare accuracy after blood pressure is elevated through aerobic exercise or low-intensity repetitive exercises, such as handgrip exercises. This study aims to follow the 2023 European Society of Hypertension recommendations by measuring blood pressure with the arm positioned vertically more than 20 centimeters below the standard position and comparing the results obtained after repeated handgrip exercises with those obtained using the standard method.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects requiring 24-hour ambulatory blood pressure monitoring | Experimental | Device: CART BP, Device: sphygmomanometerSubjects prescribed for ambulatory blood pressure monitor (ABPM) measure 24-hour blood pressure using both the CART BP and sphygmomanometer |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects aged 18 years or older but younger than 80 years
- Individuals who voluntarily decide to participate in this clinical trial and provide written consent to the information and consent form
- Individuals willing to comply with the clinical trial protocol
Key exclusion criteria (9 listed)
- Subjects who do not consent to the study
- Obese individuals with a Body Mass Index (BMI) of 30 or higher (concerns about measurement errors as the standard 24-hour ambulatory blood pressure monitor cuff may not fit the arm properly)
- Patients or volunteers who are pregnant
- Patients or volunteers with underlying heart diseases: those with a history of hospitalization for heart failure, valvular disease, or myocardial infarction
- Patients or volunteers diagnosed with atrial fibrillation on a 12-lead electrocardiogram (ECG) within the past 6 months
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 |
|---|---|---|
| CART BPA ring-type medical device worn by the subject that non-invasively measures systolic and diastolic blood pressure, as well as pulse rate. | Device | Subjects requiring 24-hour ambulatory blood pressure monitoring |
| sphygmomanometerBlood pressure measurement method utilizing a two-headed stethoscope, allowing two observers to simultaneously hear the Korotkoff sounds. | Device | Subjects requiring 24-hour ambulatory blood pressure monitoring |
Primary outcome
Mean error and standard deviations of differences between CART BP and Reference
Time frame: 1 hour
The primary outcome measure is the mean error and standard deviation (SD) of the differences between the CART BP device and the reference device. This endpoint is determined based on the European Hypertension Society (ESH) recommendation, which states that the pass criteria are as per International Organization for Standardization (ISO) 81060-2:2018: a mean error within 5 mmHg and an standard deviation within ±8 mmHg.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2025.
- Background: PubMed 30190007Carey RM, Muntner P, Bosworth HB, Whelton PK. Prevention and Control of Hypertension: JACC Health Promotion Series. J Am Coll Cardiol. 2018 Sep 11;72(11):1278-1293. doi: 10.1016/j.jacc.2018.07.008.
- Background: PubMed 37303198Stergiou GS, Avolio AP, Palatini P, Kyriakoulis KG, Schutte AE, Mieke S, Kollias A, Parati G, Asmar R, Pantazis N, Stamoulopoulos A, Asayama K, Castiglioni P, De La Sierra A, Hahn JO, Kario K, McManus RJ, Myers M, Ohkubo T, Shroff SG, Tan I, Wang J, Zhang Y, Kreutz R, O'Brien E, Mukkamala R. European Society of Hypertension recommendations for the validation of cuffless blood pressure measuring devices: European Society of Hypertension Working Group on Blood Pressure Monitoring and Cardiovascular Variability. J Hypertens. 2023 Dec 1;41(12):2074-2087. doi: 10.1097/HJH.0000000000003483. Epub 2023 Jun 22.
- Background: PubMed 31532913Kario K, Shin J, Chen CH, Buranakitjaroen P, Chia YC, Divinagracia R, Nailes J, Hoshide S, Siddique S, Sison J, Soenarta AA, Sogunuru GP, Tay JC, Teo BW, Turana Y, Zhang Y, Park S, Van Minh H, Wang JG. Expert panel consensus recommendations for ambulatory blood pressure monitoring in Asia: The HOPE Asia Network. J Clin Hypertens (Greenwich). 2019 Sep;21(9):1250-1283. doi: 10.1111/jch.13652.
- Background: PubMed 24029863O'Brien E, Parati G, Stergiou G, Asmar R, Beilin L, Bilo G, Clement D, de la Sierra A, de Leeuw P, Dolan E, Fagard R, Graves J, Head GA, Imai Y, Kario K, Lurbe E, Mallion JM, Mancia G, Mengden T, Myers M, Ogedegbe G, Ohkubo T, Omboni S, Palatini P, Redon J, Ruilope LM, Shennan A, Staessen JA, vanMontfrans G, Verdecchia P, Waeber B, Wang J, Zanchetti A, Zhang Y; European Society of Hypertension Working Group on Blood Pressure Monitoring. European Society of Hypertension position paper on ambulatory blood pressure monitoring. J Hypertens. 2013 Sep;31(9):1731-68. doi: 10.1097/HJH.0b013e328363e964.
- 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.
Seung Woo Park principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CART BP and sphygmomanometer in people with Blood Pressure and Hypertension, run by Sky Labs 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 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: looking for participants now, as of the sponsor's last update on 15 Jun 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gerrard Kim (+82-10-5192-8767, gerrard.kim@skylabs.io), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean error and standard deviations of differences between CART BP and Reference (time frame: 1 hour). 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 NCT06513975, which also lists 4 linked publications.
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 15 Jun 2025.