imPulse™ Una Infrasound-to-ultrasound E-stethoscope

May 18, 2022 updated by: Level 42 AI, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

702

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Congo, The Democratic Republic of the
    • Kouilou
      • Pointe Noire, Kouilou, Congo, The Democratic Republic of the
        • Laboratoire de la foundation Gombes
  • India
    • Odisha
      • Bhubaneswar, Odisha, India, 751002
        • Asian Institute of Public Health
  • Senegal
    • Almadies
      • Dakar, Almadies, Senegal
        • Institute for Health Research, Epidemiological Surveillance and Training ( IRESSEF)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Case
Inpatients/Outpatients with confirmed COVID-19 with and without pulmonary symptoms.
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.
Other Names:
  • RT-PCR
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.
Other Names:
  • CT
  • CAT
Matched-Control
Outpatients without COVID-19 without known non-pulmonary diagnoses or symptoms.
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.
Other Names:
  • RT-PCR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Enrollment through to study completion (min 48hrs through to 3 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
imPulse™ Una infrasound-to-ultrasound e-stethoscope device safety
Time Frame: Enrollment through to study completion (min 48hrs through to 3 months)
Device safety
Enrollment through to study completion (min 48hrs through to 3 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Level 42 AI, Inc.

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 11, 2021

Primary Completion (Actual)

February 28, 2022

Study Completion (Actual)

February 28, 2022

Study Registration Dates

First Submitted

June 20, 2021

First Submitted That Met QC Criteria

June 20, 2021

First Posted (Actual)

June 28, 2021

Study Record Updates

Last Update Posted (Actual)

May 19, 2022

Last Update Submitted That Met QC Criteria

May 18, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • L42AI-20210003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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