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

NCT03126994 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2018-08-31

No results posted yet for this study

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

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

Sponsors & Collaborators

  • PhysioWave, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-04-11
Primary Completion
2017-05-19
Completion
2017-05-19
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03126994 on ClinicalTrials.gov