Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PhysioWave Cardiovascular Analyzer | Experimental | The Experimental Device is the PhysioWave Cardiovascular Analyzer, which will be used to measure Pulse Wave Velocity, Pulse Rate, Body Weight, and BMI. This will be compared to FDA-cleared devices to determine equivalence: AtCor XCEL PWA & PWV to measure Pulse Wave Velocity and Pulse rate, and Detecto SOLO to measure Body Weight and BMI. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PhysioWave Cardiovascular Analyzer | Device | Measurement of Pulse Wave Velocity, Pulse Rate, Body Weight and BMI |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Day 1 |
| Secondary Objective: Precision Analysis, PWV |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory Analysis: Impact of Strong Vasoactive Drugs on PWV Equivalence | An exploratory analysis will be conducted to evaluate any effects of strong vasoactive drugs, such as those used to control high blood pressure, on equivalency when measuring: pulse wave velocity (PWV) (in m/s) between the PhysioWave Cardiovascular Analyzer and AtCor Medical SphygmoCor® XCEL PWA & PWV. | Day 1 |
Inclusion Criteria:
Subgroup Inclusion Criteria
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Diablo Clinical Research | Walnut Creek | California | 94598 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D063177 | Pulse Wave Analysis |
| ID | Term |
|---|---|
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
Not provided
Not provided
Prospective validation study to evaluate PWV, PR, and BW accuracy in a sample of subjects representing the US general adult population.
Not provided
Not provided
Not provided
Not provided
| AtCor XCEL PWA & PWV | Device | Measurement of Pulse Wave Velocity and Pulse Rate |
|
| Detecto SOLO | Device | Measurement of Body Weight and BMI |
|
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).
| 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). | 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). | 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). | Day 1 or Day 2 |
| Exploratory Analysis: Impact of BMI on PWV Equivalence | An exploratory analysis will be conducted to evaluate any effect(s) of BMI (in kg/m^2) on equivalency when measuring: pulse wave velocity (PWV) (in m/s) between the PhysioWave Cardiovascular Analyzer and AtCor Medical SphygmoCor® XCEL PWA & PWV. | Day 1 |