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

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 Overview

• Status: Completed
• Conditions: Cardiovascular Risk Factor
• Intervention / Treatment: Device: PhysioWave Cardiovascular Analyzer; Device: AtCor XCEL PWA & PWV; Device: Detecto SOLO

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Walnut Creek, California, United States, 94598
      • Diablo Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects >18 years old
• Subject signs a written Informed Consent form to participate in the study, prior to any study procedures

Subgroup Inclusion Criteria

• Subject has been taking ACE Inhibitors or Angiotensin Receptor Blockers for at least 30 days

Exclusion Criteria:

• Known significant carotid or femoral artery stenosis
• Non-palpable (non-detectable) arterial pulse at the sites of measurements
• Pacemaker, defibrillator, or other cardiac stimulator
• Erratic, accelerated or mechanically controlled irregular heart rhythm, or an arrhythmia
• History of cardiac valve disorder or cardiac valve disease
• History of venous disease, including venous insufficiency or deep vein thrombosis
• History of peripheral artery disease
• Requirement for supplemental oxygen
• Neuromuscular disorders that cause shaking or tremors (such as Parkinson's disease or Multiple Sclerosis), or other disease or condition affecting balance
• Amputation or malformation of any limb or extremity (foot, leg, or arm) which would impede the placement of blood pressure cuffs or standing on the scale with two feet.
• Known or suspected pregnancy
• Inability to provide informed consent
• Mental incompetence or a prisoner status
• Current participation in a clinical trial of another investigational drug or device in which the study endpoint has not been met
• BMI > 40
• Subjects > 400 lbs
• Subjects on strong vasoactive drugs, such as those used to control high blood pressure, for <30 days
• Blood loss or blood donation of ˃ 550 mL within 30 days before study procedure

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: PhysioWave Cardiovascular Analyzer; 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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: PhysioWave, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 11, 2017
• Primary Completion (ACTUAL): May 19, 2017
• Study Completion (ACTUAL): May 19, 2017

Study Registration Dates

• First Submitted: April 10, 2017
• First Submitted That Met QC Criteria: April 19, 2017
• First Posted (ACTUAL): April 25, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 31, 2018
• Last Update Submitted That Met QC Criteria: August 29, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 780-00033

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No