imPulse™ Una Infrasound-to-ultrasound E-stethoscope

NCT04941209 | Completed

• 1 other identifier: L42AI-20210003
• Study Type: observational
• Target: 702
• Locations: 3 countries
• Sites: 3

Brief 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.

Conditions

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

Keywords

infrasound; ultrasound; vibroacoustics; vibrome; digital-biosignature; e-stethoscope

Outcome Measures

Primary Outcomes (1)

• Digital vibroacoustic biomarker diagnostic performance characteristics

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

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

Secondary Outcomes (1)

• imPulse™ Una infrasound-to-ultrasound e-stethoscope device safety

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

Study Arms (2)

Case

Inpatients/Outpatients with confirmed COVID-19 with and without pulmonary symptoms.

Device: imPulse™ Una infrasound-to-ultrasound e-stethoscope; Diagnostic Test: (PPA >95%) FDA EUA RT-PCR; Radiation: HR-CT-scan

Matched-Control

Outpatients without COVID-19 without known non-pulmonary diagnoses or symptoms.

Device: imPulse™ Una infrasound-to-ultrasound e-stethoscope; Diagnostic Test: (PPA >95%) FDA EUA RT-PCR

Interventions

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.

Case; Matched-Control

(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.

Also known as: RT-PCR

Case; Matched-Control

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.

Also known as: CT, CAT

Case

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Women/girls and men/boys meeting enrollment criteria will be recruited from among hospitalized inpatients and outpatients with asymptomatic and symptomatic COVID-19 infection. One outpatient control without lung disease or pulmonary symptoms will be selected for each enrolled case.

You may qualify if:

• 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.

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

Sponsors & Collaborators

• Level 42 AI, Inc.: lead
• Asian Institute of Public Health: collaborator
• Institut de Recherche en Santé de Surveillance Epidemiologique et de Formation (IRESSEF): collaborator
• Laboratoire de la foundation Gombes: collaborator

Study Sites (3)

Laboratoire de la foundation Gombes

Pointe Noire, Kouilou, Democratic Republic of the Congo

Location

Asian Institute of Public Health

Bhubaneswar, Odisha, 751002, India

Location

Institute for Health Research, Epidemiological Surveillance and Training ( IRESSEF)

Dakar, Almadies, Senegal

Location

Related Links

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

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Interventions

COVID-19 Nucleic Acid Testing

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

COVID-19 Testing; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2021
• First Posted: June 28, 2021
• Study Start: June 11, 2021
• Primary Completion: February 28, 2022
• Study Completion: February 28, 2022
• Last Updated: May 19, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1); SE (1); IN (1)