Status:
COMPLETED
Evaluation of the AudibleHealth Dx AI/ML-Based Dx SaMD Using FCV-SDS in the Diagnosis of COVID-19 Illness: Clinical Validation
Lead Sponsor:
AudibleHealth AI, Inc.
Collaborating Sponsors:
Sunrise Research Institute
Analytical Solutions Group, Inc.
Conditions:
2019 Novel Coronavirus Disease
2019 Novel Coronavirus Infection
Eligibility:
All Genders
18-100 years
Brief 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)...
Detailed Description
The study is a prospective, multi-site, non-inferiority trial comparing the AudibleHealth Dx to FDA approved COVID-19 RT-PCR testing to demonstrate non-inferiority of the PPA and NPA when using this d...
Eligibility Criteria
Inclusion
- 18 years of age or older
- Present for elective, outpatient COVID-19 RT-PCR testing
- Meet the FDA EUA approved indications for use for RT-PCR nasal swab testing 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
- Ability to complete both the informed consent form and the screens on the medical device app in English (no translation to other languages is currently available)
Exclusion
- Any individual who was a part of the AudibleHealth Dx Development, Training, and Usability trial (Training and test data sets are to be kept strictly separate.)
- Less than 18 years of age
- Unable to produce a voluntary forced cough vocalization (FCV)
- Recent 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
Key Trial Info
Start Date :
May 4 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2022
Estimated Enrollment :
514 Patients enrolled
Trial Details
Trial ID
NCT05364268
Start Date
May 4 2022
End Date
June 1 2022
Last Update
July 20 2022
Active Locations (1)
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1
Sunrise Research Institute
Sunrise, Florida, United States, 33325