imPulse™ Una Infrasound-to-ultrasound E-stethoscope

Level 42 AI

Status

Completed

Conditions

COVID-19 Respiratory Infection

COVID-19 Pneumonia

Corona Virus Infection

COVID-19 Acute Respiratory Distress Syndrome

Covid19

Vaccine Virus Shedding

Mass Screening

Treatments

Diagnostic Test: (PPA >95%) FDA EUA RT-PCR

Device: imPulse™ Una infrasound-to-ultrasound e-stethoscope

Radiation: HR-CT-scan

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT04941209

L42AI-20210003

Details and patient eligibility

About

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.

Full description

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.

Enrollment

702 patients

Sex

All

Ages

6+ years old

Volunteers

No Healthy Volunteers

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