Validating the CART BP ring cuffless blood pressure monitor
Validation Study of CART BP as a Wearable Cuffless Blood Pressure Monitor: Evaluation of Blood Pressure Measurement by Height and Physical Activity
This study will test whether the CART BP ring gives blood pressure readings that match the standard cuff method in adults with suspected high or low blood pressure.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Sky Labs Industry-sponsored |
| Drugs / interventions | CART |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06513975 on ClinicalTrials.gov |
What this trial studies
The trial compares the CART BP, a ring-type cuffless monitor that uses photoplethysmography (PPG), against auscultatory cuff measurements following the 2023 European Society of Hypertension (ESH) recommendations. Measurements will be taken across different arm positions and before and after exercise challenges (aerobic and repeated handgrip) to capture variations in blood pressure. Adult participants aged 18–79 with suspected hypertension or hypotension will have paired readings from the CART BP and a dual-head stethoscope reference method. The protocol excludes people with high BMI, atrial fibrillation, recent major heart disease, end-stage renal disease, pregnancy, or inability to perform repeated exercises.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18–79 with suspected high or low blood pressure who can give consent, follow the protocol, and attend in-person testing at the study site.
Not a fit: People with BMI ≥30, recent atrial fibrillation, serious cardiac disease, end-stage renal disease, pregnancy, or those unable to perform the required exercises are unlikely to benefit from this device within the study.
Why it matters
Potential benefit: If successful, the CART BP ring could make blood pressure checks more comfortable and enable longer or more frequent monitoring without a cuff.
How similar studies have performed: Previous research on cuffless PPG-based devices has shown promising results in controlled settings but has produced variable accuracy overall, so independent validation using ESH criteria remains important.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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) * 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)
Where this trial is running
Seoul
- Samsung Medical Center — Seoul, South Korea (Recruiting)
Study contacts
- Principal investigator: Seung Woo Park — Samsung Medical Center
- Study coordinator: Gerrard Kim
- Email: gerrard.kim@skylabs.io
- Phone: +82-10-5192-8767
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.