Evaluation of the AudibleHealth Dx AI/ML-Based Dx SaMD Using FCV-SDS in the Diagnosis of COVID-19 Illness
NCT ID: NCT05175690
Last Updated: 2022-05-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1126 participants
OBSERVATIONAL
2022-01-10
2022-05-03
Brief Summary
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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. Bidirectional Sanger sequencing will be used to reduce the rate of false negative and false positive results.
A secondary purpose of the study will be usability testing of the device for participants and providers.
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Detailed Description
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Target enrollment for this trial will be 65 COVID-19 positive cases and 247 COVID-19 negative cases, presuming a prevalence of 0.17 for a total of 312 subjects meeting all inclusion criteria.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Trial Population
The trial population will be enrolled from adults presenting for elective, outpatient COVID-19 testing at a single center, potentially with multiple testing locations (subject to local needs at the time of the trial). The investigational device will be provided to Participants via a cell phone preloaded with Common off-the-shelf original equipment manufacturer (COTS OEM) software and the investigational Dx SaMD. The investigational device will be evaluated during a single encounter in which an FCV-SDS will be collected. No follow-up visits or participant contacts will be involved in this trial.
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.
The AudibleHealth Dx is a cloud-based AI/ML (locked ML) diagnostic software as medical device (Dx SaMD) with a mobile app based graphical user interface (GUI) designed to operate with COTS Android Operating System (OS) and Apple OS based mobile devices. The AudibleHealth Dx system uses a forced cough vocalization (FCV) signal data signature (SDS) to diagnose COVID-19 illness in ambulatory adults. Results are sent to ordering physicians, State Health Departments, and participants using Health Level 7 (HL7) compliant communication protocols.
Interventions
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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.
The AudibleHealth Dx is a cloud-based AI/ML (locked ML) diagnostic software as medical device (Dx SaMD) with a mobile app based graphical user interface (GUI) designed to operate with COTS Android Operating System (OS) and Apple OS based mobile devices. The AudibleHealth Dx system uses a forced cough vocalization (FCV) signal data signature (SDS) to diagnose COVID-19 illness in ambulatory adults. Results are sent to ordering physicians, State Health Departments, and participants using Health Level 7 (HL7) compliant communication protocols.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Present for elective, outpatient COVID-19 RT-PCR testing
* Meet the FDA EUA approved indications for use for the RT-PCR nasal swab test for COVID-19
* Stated willingness to comply with all trial procedures and availability for the duration of the trial
* Informed consent must be obtained prior to testing
Exclusion Criteria
* Unable to cough voluntarily
* Present with acute traumatic injury to the head, neck, throat, chest, abdomen or trunk
* Patent tracheostomy stoma
* Recent chest/abdomen/trunk trauma or surgery, recent/persistent neurovascular injury or recent intracranial surgery
* Medical history of cribriform plate injury or cribriform plate surgery, diaphragmatic hernia, external beam neck/throat/maxillofacial radiation, phrenic nerve injury/palsy, radical neck/throat/maxillofacial surgery, vocal cord trauma or nodules
* Since persons with aphasia may have difficulty in producing an FCV-SDS in the time allotted by the app, this population also will be excluded from the current trial
18 Years
ALL
Yes
Sponsors
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University of South Florida
OTHER
R. P. Chiacchierini Consulting, LLC
INDUSTRY
Analytical Solutions Group, Inc.
UNKNOWN
Renaissance Worldwide Solutions, LLC
UNKNOWN
Medical & Regulatory Affairs Specialists, LLC
UNKNOWN
AudibleHealth AI, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Karl Kelley, MD
Role: PRINCIPAL_INVESTIGATOR
RAIsonance, Inc.
Locations
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University of South Florida
Tampa, Florida, United States
Countries
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References
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Other Identifiers
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Pro00057996
Identifier Type: -
Identifier Source: org_study_id
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