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Pivotal Clinical Trial to Evaluate the Blood Pressure Accuracy of 'CART-I Plus'

NCT05725148 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-02-13

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

CART-I plus

CART-I plus is a ring-type medical device that continuously monitors Atrial Fibrillation, heart rate, oxygen saturation, and blood pressure using PPG and ECG signals.

Sponsors & Collaborators

  • Sky Labs

    lead INDUSTRY

Principal Investigators

  • Seung Woo Park, MD, PhD · Samsung Medical Center

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-15
Primary Completion
2022-12-23
Completion
2022-12-23

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05725148 on ClinicalTrials.gov