Skip to main content
OpenTrials
Completed

NCT Number: NCT04941209

imPulse™ Una Infrasound-to-ultrasound E-stethoscope

This study generates robust, uniform clinical data across emerging COVID-19 strains to train ML/AI algorithms of the Sponsor's imPulse™ Una infrasound-to-ultrasound e-stethoscope for digital diagnostic feature synthesis of asymptomatic and symptomatic COVID-19 digital biosignatures for rapid and accurate adult and child mass screening.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Covid19 COVID-19 COVID-19 Acute Respiratory Distress Syndrome COVID-19 Pneumonia COVID-19 Respiratory Infection Corona Virus Infection Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Mass Screening Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Vaccine Virus Shedding Virus Diseases

Age range

6 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Laboratoire de la foundation Gombes, Pointe Noire, Kouilou, Democratic Republic of the Congo

Loading trial locations.

About this study

For the next few years or more, the planet probably won't have enough vaccine for everyone. Even as countries with large COVID-19 vaccination programs start pushing to resume travel and trade:

We will not know who is vaccinated and who is not . We will not know who is an (a)symptomatic COVID-19 carrier and who is not.

Because of this, the global community will remain in various stages of masking, social distancing, lock-down, and limited congregation because of cyclical COVID-19 spikes and people will continue to feel unsafe and afraid as novel COVID-19 variants appear and disappear.

This large-scale, multi-site, multi-national study is informed by a completed pilot study at Johns Hopkins- NCT04556149. This study is designed to validate the ability of the imPulse™ Una infrasound-to-ultrasound e-stethoscope to rapidly and accurately screen outpatients with and without confirmed COVID-19 with sensitivity, specificity, positive and negative predictive value matching (PPA >95%) for early, accurate, and rapid, self-directed and point-of-care diagnosis of COVID-19 in areas still lagging in access to vaccines.

Who can participate

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

Inclusion criteria

  • Able to understand and willingness to comply with study procedures
  • Inpatient Cases - hospitalized patients with positive COVID-19 PCR test, collected from a respiratory sample within the last 7 days, AND pulmonary symptoms within 72 hours of enrollment
  • Outpatient Cases - participant being screened for COVID-19 with positive COVID-19 PCR test respiratory sample Controls - Outpatients with negative COVID-19 PCR test respiratory sample 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 infrasound-to-ultrasound 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.

(PPA >95%) FDA EUA RT-PCR

Diagnostic Test

Real-time RT-PCR that detects amplified SARS-CoV-2 genome in sputum, nasopharyngeal or oropharyngeal swabs, bronchoalveolar lavage fluid, nasal or nasopharyngeal aspirate, and lower respiratory tract aspirates.

Other names: RT-PCR

HR-CT-scan

Radiation

High-resolution computer tomography, or CT/CAT, is an X-ray scan that produces images of the chest and is used as a confirmatory test in symptomatic patients that have a negative PCR test.

Other names: CT, CAT

Primary outcomes

  1. Digital vibroacoustic biomarker diagnostic performance characteristics

    Time frame: Enrollment through to study completion (min 48hrs through to 3 months)

    Sensitivity, specificity, positive and negative predictive values - of the imPulse™ Una device for point-of-care diagnosis of COVID-19.

Secondary outcomes

  1. imPulse™ Una infrasound-to-ultrasound e-stethoscope device safety

    Time frame: Enrollment through to study completion (min 48hrs through to 3 months)

    Device safety

Sponsors and collaborators

Lead sponsor

Level 42 AI, Inc.

Industry

Collaborators

  • Asian Institute of Public Health
  • Institut de Recherche en Santé de Surveillance Epidemiologique et de Formation (IRESSEF)
  • Laboratoire de la foundation Gombes

Registry information

Official study title

imPulse™ Una Infrasound-to-ultrasound E-stethoscope 2-minute to Result COVID-19 Self-directed & Point-of-care Screening Test

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 28, 2021
Registry last updated
May 19, 2022

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.