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Repeatability and Reproducibility of the CADence™System

NCT03793049 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 79

Last updated 2019-07-10

No results posted yet for this study

Summary

This study is designed as a prospective study to capture data for evaluating the repeatability and reproducibility of the CADence™ System. The study will be conducted at 3 different study sites using 6 CADence™ systems. Each subject will be tested 4 separate times by 2 different operators at each site and will be tested at all 3 site locations in order to accomplish this evaluation. The study will enroll a total of at least 24 CADence positive patients and at least 24 CADence negative patients.

Conditions

Interventions

DEVICE

CADence testing will be performed

CADence is a noninvasive, handheld device comprised of acoustic and ECG technology and software

Sponsors & Collaborators

  • AUM Cardiovascular, Inc.

    lead INDUSTRY

Principal Investigators

  • ROBERT WILSON, MD · University of Minnesota

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-23
Primary Completion
2019-06-26
Completion
2019-06-26
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

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 NCT03793049 on ClinicalTrials.gov