RecruitingNCT06560034

VicorderCS NIBP Validation Study to Review The Ability to Capture Blood Pressure Measurements

VicorderCS NIBP Validation Study to Assess Its Ability to Capture Blood Pressure Measurements


Sponsor

80 Beats Medical

Enrollment

120 participants

Start Date

Aug 15, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

80 Beats Medical introduces the VicorderCS, the next generation of our Vicorder technology designed to manage hypertension and cardiovascular risks. This advanced diagnostic equipment offers non-invasive collection and computation of a plethora of cardiovascular markers. It is faster, easier to use, and more portable than its predecessor, with enhanced connectivity options for extended marker collection and analysis. These markers enable early diagnosis of cardiovascular disease, ensuring positive patient outcomes. With a strong foundation in numerous published clinical studies, the VicorderCS enhances data collection and analysis capabilities, empowering the research community in developing new drugs and therapeutics. This validation study is purposed to evaluate one of the physiological parameters that is measured by the VicorderCS system, which is Non-invasive Blood Pressure (NIBP) via the common oscillometric cuff-based method.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests how accurately a non-invasive wrist-worn device called VicorderCS can measure blood pressure without using a traditional arm cuff, by comparing its readings to validated clinical blood pressure measurements taken in the same session. The goal is to determine whether the device is reliable enough for everyday use in monitoring cardiovascular health. **You may be eligible if...** - You are aged 18 or older and in generally good health - You are willing to have your blood pressure measured during a single study visit - You are able to read, speak, and understand English - You have an active email address **You may NOT be eligible if...** - You have a significantly irregular heart rhythm (such as atrial fibrillation, bigeminy, or frequent abnormal heartbeats) - You are pregnant - You do not speak or read English Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEVicorderCS

1. Vascular Sensor (VCS-VAS-1000) measurement device used with accessories (cuffs and tubes) connected to the device; 2. Data Station (VCS-DAT-1000) for data collection and analysis


Locations(1)

Manos Health Study Site

Breckenridge, Colorado, United States

View Full Details on ClinicalTrials.gov

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NCT06560034


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