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Completed
NCT05725148
Pivotal Clinical Trial to Evaluate the Blood Pressure Accuracy of 'CART-I Plus'
Conditions: Blood Pressure, Hypertension, Hypotension
Sex: All
Ages: 19 Years – N/A
Healthy volunteers: 1
Phase: NA
Enrollment: 100
Sponsor: Sky Labs
Location: Korea, Republic of
Summary
The goal of this clinical trial is to evaluate how accurately the CART-I plus developed by Sky Labs can measure blood pressure.
The primary endpoint of this clinical trial is accuracy (mmHg) of 'CART-I plus' which is obtained by calculating mean error and standard deviation of blood pressure differences between 'CART-I plus' and the gold standard for non-invasive method, auscultatory method.
The reference readings are taken by auscultatory method using a sphygmomanometer and a stethoscope.
The mean errors and standard deviations are calculated both sample- and subject-wise.
Eligibility Criteria
Inclusion Criteria:Those aged 19 or olderThose who voluntarily decided to participate in this clinical trial and gave written consent to the subject explanation and consent formThose who is willing to comply with the clinical trial protocolExclusion Criteria:Those whose sound of fifth Kortkoff phase (K5) is not heard during blood pressure test using an auscultation type sphygmomanometerThose with unstable cardiac condition (myocardial infarction, ventricular arrhythmia, atrial fibrillation, premature ventricular contraction, pulmonary embolism 1 week before screening date)Those with arm circumference greater than 42 cm (> 42 cm)Those with a history of hypersensitivity to clinical trial medical device raw materials (PolyCarbonate, polycarbonate)Those with physical restrictions on wearing medical devices for clinical trials (for example, when ring-type clinical trial medical devices cannot be applied due to lack of appropriate ring size or other physical defects)Those who are judged to have difficulty collecting normal signals when wearing CART-I plus on a finger other than the thumb and forefinger (for example, if there is no CART-I plus model that fits the subject's finger)Those who is pregnantThose who is currently participating in other clinical trials or who have participated in other clinical trials within 30 days of the screening dateOther cases where the investigator judges that participation in the clinical trial is inappropriate due to ethical reasons or may affect the results of the clinical trial
Source: ClinicalTrials.gov (NCT05725148). StuddyBuddy aggregates publicly available trial information.
