NCT04941209

imPulse™ Una Infrasound-to-ultrasound E-stethoscope

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 702 (actual)
• Sponsor: Level 42 AI, Inc. · Industry
• Sex: All
• Age: 6 Years
• Healthy volunteers: —

Summary

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.

Detailed 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.

Conditions

• Covid19
• COVID-19 Pneumonia
• COVID-19 Respiratory Infection
• COVID-19 Acute Respiratory Distress Syndrome
• Mass Screening
• Corona Virus Infection
• Vaccine Virus Shedding

Interventions

Type	Name	Description
DEVICE	imPulse™ Una infrasound-to-ultrasound e-stethoscope	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.
DIAGNOSTIC_TEST	(PPA >95%) FDA EUA RT-PCR	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.
RADIATION	HR-CT-scan	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.

Timeline

• Start date: 2021-06-11
• Primary completion: 2022-02-28
• Completion: 2022-02-28
• First posted: 2021-06-28
• Last updated: 2022-05-19

Locations

3 sites across 3 countries: Democratic Republic of the Congo, India, Senegal