Status:
RECRUITING
Validation Study of CART BP as a Wearable Cuffless Blood Pressure Monitor
Lead Sponsor:
Sky Labs
Collaborating Sponsors:
Samsung Medical Center
Conditions:
Blood Pressure
Hypertension
Eligibility:
All Genders
18-80 years
Phase:
NA
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 ...
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 diode...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
November 22 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 15 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06513975
Start Date
November 22 2024
End Date
August 15 2025
Last Update
June 15 2025
Active Locations (1)
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1
Samsung Medical Center
Seoul, South Korea