This is a prospective, single-center, non-randomized validation study being conducted under a non-significant risk study design with the primary aim to evaluate PWV, PR, and BW accuracy in a sample of subjects representative of the US general adult population. The primary study objective is to demonstrate equivalency when measuring: Pulse Wave Velocity (PWV) and Pulse Rate (PR) between the PhysioWave Cardiovascular Analyzer (CA) and AtCor Medical SphygmoCor® XCEL PWA \& PWV (XCEL), and Body Weight (BW) between the CA and the Detecto Solo Digital Healthcare Scale (Detecto).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
160
Measurement of Pulse Wave Velocity, Pulse Rate, Body Weight and BMI
Measurement of Pulse Wave Velocity and Pulse Rate
Measurement of Body Weight and BMI
Diablo Clinical Research
Walnut Creek, California, United States
Primary Objective: PWV Equivalence
The first primary study objective is to demonstrate equivalency when measuring: pulse wave velocity (PWV) (in m/s) between the PhysioWave Cardiovascular Analyzer and AtCor Medical SphygmoCor® XCEL PWA \& PWV.
Time frame: Day 1
Pulse Rate Equivalence
The second primary study objective is to demonstrate equivalency when measuring: pulse rate (in bpm) between the PhysioWave Cardiovascular Analyzer and AtCor Medical SphygmoCor® XCEL PWA \& PWV.
Time frame: Day 1
Body Weight Equivalence
The third primary study objective is to demonstrate equivalency when measuring body weight (in kg) between the PhysioWave Cardiovascular Analyzer and the Detecto Solo.
Time frame: Day 1
Secondary Objective: BMI Equivalence
Demonstrate equivalency when measuring Body Mass Index (BMI) (in kg/m\^2) between the PhysioWave Cardiovascular Analyzer and the Detecto Solo
Time frame: Day 1
Secondary Objective: Precision Analysis, PWV
Evaluate the precision of PWV measurements (in m/s) due to the sources of variation in measurements in the PhysioWave Cardiovascular Analyzer and AtCor Medical SphygmoCor® XCEL PWA \& PWV. Sources of variation to be assessed include between-replicates, between-device, between-operator, and total (overall).
Time frame: Day 1 or Day 2
Secondary Objective: Precision Analysis, Pulse Rate
Evaluate the precision of pulse rate measurements (in bpm) due to the sources of variation in measurements in the PhysioWave Cardiovascular Analyzer and AtCor Medical SphygmoCor® XCEL PWA \& PWV. Sources of variation to be assessed include between-replicates, between-device, between-operator, and total (overall).
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Time frame: Day 1 or Day 2
Secondary Objective: Precision Analysis, Body Weight
Evaluate the precision of body weight measurements (in kg) due to the sources of variation in measurements in the PhysioWave Cardiovascular Analyzer and the Detecto Solo. Sources of variation to be assessed include between-replicates, between-device, between-operator, and total (overall).
Time frame: Day 1 or Day 2
Secondary Objective: Precision Analysis, BMI
Evaluate the precision of BMI measurements (in kg/m\^2) due to the sources of variation in measurements in the PhysioWave Cardiovascular Analyzer and the Detecto Solo. Sources of variation to be assessed include between-replicates, between-device, between-operator, and total (overall).
Time frame: Day 1 or Day 2