imPulse™ Una Full-spectrum, Over Clothing E-stethoscope

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Corona Virus Infection
Coronavirus
Coronavirus Infections
Severe Acute Respiratory Syndrome

Clinical Trial Details

NCT number	NCT04556149
Study type	Observational
Source	Level 42 AI, Inc.
Contact
Status	Completed
Phase
Start date	October 1, 2020
Completion date	December 2, 2020

View Details

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