NCT03126994

Prospective, Single-Center, Non-Randomized Study of the PhysioWave™ Cardiovascular Analyzer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: PhysioWave, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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).

Conditions

• Cardiovascular Risk Factor

Interventions

Type	Name	Description
DEVICE	PhysioWave Cardiovascular Analyzer	Measurement of Pulse Wave Velocity, Pulse Rate, Body Weight and BMI
DEVICE	AtCor XCEL PWA & PWV	Measurement of Pulse Wave Velocity and Pulse Rate
DEVICE	Detecto SOLO	Measurement of Body Weight and BMI

Timeline

• Start date: 2017-04-11
• Primary completion: 2017-05-19
• Completion: 2017-05-19
• First posted: 2017-04-25
• Last updated: 2018-08-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study