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

Completed

Conditions studied: Corona Virus Infection, Coronavirus

In brief

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.

Key facts

Study ID

NCT04556149

Run by

Level 42 AI, Inc.

People needed

34

Starts

2020-10-01

Expected to finish

2020-12-02

Last updated by the study team

2020-12-21

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Individuals hospitalized within a Johns Hopkins-affiliated hospital
• Able to understand and willingness to comply with study procedures
• Cases - inpatients with positive COVID-19 PCR test, collected from a respiratory sample within the last 7 days, AND pulmonary symptoms within 72 hours of enrollment
• Controls - inpatients without COVID-19 diagnosis and no pulmonary diagnosis or symptoms
• Cases or Control not able to sit or stand will be allowed to participate in just the parts of the staircase exam they're capable of doing.

You may not qualify if…

• Assisted ventilation, including high flow nasal cannula, or ventilator support
• Unable to comply with study procedures, defined at investigator's discretion
• Participants with any visible skin infections or open wounds in areas where the imPulse™ Una device would be applied

Where it is running

• Johns Hopkins School of Medicine — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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