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imPulse™ Una Infrasound-to-ultrasound E-stethoscope

NCT04941209 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 702

Last updated 2022-05-19

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Asian Institute of Public Health

    collaborator OTHER

  • Institut de Recherche en Santé de Surveillance Epidemiologique et de Formation (IRESSEF)

    collaborator UNKNOWN

  • Laboratoire de la foundation Gombes

    collaborator UNKNOWN

  • Level 42 AI, Inc.

    lead INDUSTRY

Eligibility

Min Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-11
Primary Completion
2022-02-28
Completion
2022-02-28

Countries

  • Democratic Republic of the Congo
  • India
  • Senegal

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04941209 on ClinicalTrials.gov