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Completed

NCT Number: NCT04556149

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

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.

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Key information

Conditions

Corona Virus Infection Coronaviridae Infections Coronavirus Coronavirus Infections Infections Nidovirales Infections RNA Virus Infections Virus Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Johns Hopkins School of Medicine

Baltimore, Maryland, 21287-5554, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

imPulse™ Una e-stethoscope

Device

The imPulse™ System is an every/anywhere-point-of-care cardiopulmonary functional state assessment platform designed to capture normal and abnormal, audible and inaudible cardiopulmonary sounds, rhythms and patterns, via a real-time, intelligent, full-spectrum phonocardiogram obtained from direct to skin coupling or through a layer of clothing.

Philips Lumify Ultrasound System

Device

Point-of-care ultrasound

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Level 42 AI, Inc.

Industry

Collaborators

  • Johns Hopkins University
  • Schmidt Futures

Registry information

Official study title

SARS-CoV-2/COVID-19 Study of the Audible and Inaudible Vibroacoustic E-stethoscope - imPulse™ Una

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Sep 21, 2020
Registry last updated
Dec 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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