SARS-CoV-2/COVID-19 Study of the Audible and Inaudible Vibroacoustic E-stethoscope - imPulse™ Una
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Corona Virus Infection
- Sponsor
- Level 42 AI, Inc.
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- Diagnostic performance characteristics
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
This study generates robust clinical data to train ML/AI algorithms of the Sponsor's imPulse™ Una full-spectrum e-stethoscope for digital diagnostic feature synthesis of symptomatic SARS-CoV-2/COVID-19 biosignatures for rapid and accurate mass screening.
Detailed Description
This study is designed to evaluate the ability of the imPulse™ Una e-stethoscope to differentiate vibroacoustic signals in inpatients with and without confirmed COVID-19 as the first step to establish the performance characteristics - sensitivity, specificity, positive and negative predictive value - of the imPulse™ Una device for early and rapid, point-of-care diagnosis of COVID-19. This will inform the utility and design of further larger-scale studies using the device.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Diagnostic performance characteristics
Time Frame: through study completion, an average of 2 weeks
Sensitivity, specificity, positive and negative predictive values - of the imPulse™ Una device for point-of-care diagnosis of COVID-19.