NCT06513975 Validation Study of CART BP as a Wearable Cuffless Blood Pressure Monitor
| NCT ID | NCT06513975 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sky Labs |
| Condition | Blood Pressure |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-11-22 |
| Primary Completion | 2025-08-15 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2024-11-22 with a primary completion date of 2025-08-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility 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)
Contact & Investigator
Seung Woo Park
PRINCIPAL INVESTIGATOR
Samsung Medical Center
Frequently Asked Questions
Who can join the NCT06513975 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Blood Pressure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06513975 currently recruiting?
Yes, NCT06513975 is actively recruiting participants. Contact the research team at gerrard.kim@skylabs.io for enrollment information.
Where is the NCT06513975 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT06513975 clinical trial?
NCT06513975 is sponsored by Sky Labs. The principal investigator is Seung Woo Park at Samsung Medical Center. The trial plans to enroll 50 participants.