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Evaluation of the AudibleHealth Dx AI/ML-Based Dx SaMD Using FCV-SDS in the Diagnosis of COVID-19 Illness: Clinical Validation

NCT05364268 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 514

Last updated 2022-07-20

No results posted yet for this study

Summary

The AudibleHealth Dx is a diagnostic software as a medical device (Dx SaMD) consisting of an ensemble of software subroutines that interacts with a proprietary database of Signal Data Signatures (SDS), using Artificial Intelligence/Machine Learning (AI/ML) to analyze forced cough vocalization signal data signatures (FCV-SDS) for diagnostic purposes.

This study will evaluate the performance of the AudibleHealth Dx in comparison to a standard of care Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) test for the diagnosis of COVID-19.

A secondary purpose of the study will be usability testing of the device for participants and providers.

Conditions

  • 2019 Novel Coronavirus Disease
  • 2019 Novel Coronavirus Infection
  • 2019-nCoV Disease
  • COVID-19 Pandemic
  • COVID-19 Virus Disease
  • COVID-19 Virus Infection
  • Coronavirus Disease 2019
  • Coronavirus Disease-19
  • SARS-CoV-2 Infection

Interventions

DEVICE

Diagnostic Test: Diagnostic Software as Medical Device

AudibleHealth Dx is an investigational Dx SaMD consisting of an ensemble of software subroutines that interacts with a proprietary database of signal data signatures (SDS) using Artificial Intelligence/Machine Learning (AI/ML) to analyze forced cough vocalization signal data signatures (FCV-SDS) for diagnostic purposes. The intended use for the AudibleHealth Dx AI/ML-based Dx SaMD using FCV-SDS is for the diagnosis of acute and chronic illnesses, specifically COVID-19 illness for this study.

Sponsors & Collaborators

  • Sunrise Research Institute

    collaborator UNKNOWN

  • Analytical Solutions Group, Inc.

    collaborator UNKNOWN

  • Kelley Medical Consultants LLC

    collaborator UNKNOWN

  • R. P. Chiacchierini Consulting, LLC

    collaborator INDUSTRY

  • AudibleHealth AI, Inc.

    lead INDUSTRY

Principal Investigators

  • Karl Kelley, MD · RAIsonance, Inc.

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-05-04
Primary Completion
2022-06-01
Completion
2022-06-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT05364268 on ClinicalTrials.gov