VicorderCS NIBP Validation Study to Assess Its Ability to Capture Blood Pressure Measurements
80 Beats Medical
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.
Description
The VicorderCS will enable medical personnel to conduct Blood Pressure measurement procedures for the evaluation of a participant's cardiovascular health. Clinical Rationale This study will compare the accuracy of the 80 Beats Medical noninvasive blood pressure measurement using the VicorderCS device with that of human observers' readings using the auscultatory method, as required by the applicable ISO standard: Non-invasive sphygmomanometers part 2 - clinical investigation of intermittent automated measurement type1. The study will aim to enroll 120 participants for blood pressure readings u…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Not specified
Inclusion Criteria: * Any gender, in good general health * Must be 18 years old or older, inclusive at enrollment * Must be willing to provide blood pressure measurement * Must be able to read, understand, and willingly sign an Informed Consent Form * Must be able to read, speak and understand English * Must be available to attend one study visit at: please specify exact location. Exclusion Criteria: * Excluding subjects with significantly irregular heart rhythm (e.g. Bigeminy, trigeminy, isolated ventricular premature beat (VPB), atrial fibrillation) or are pregnant * No active email addre…
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
Location
- Manos Health Study SiteBreckenridge, Colorado