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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04556149
Other study ID # 00110011
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 1, 2020
Est. completion date December 2, 2020

Study information

Verified date December 2020
Source Level 42 AI, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study generates robust clinical data to train ML/AI algorithms of the Sponsor's imPulse™ Una full-spectrum e-stethoscope for digital diagnostic feature synthesis of symptomatic SARS-CoV-2/COVID-19 biosignatures for rapid and accurate mass screening.


Description:

This study is designed to evaluate the ability of the imPulse™ Una e-stethoscope to differentiate vibroacoustic signals in inpatients with and without confirmed COVID-19 as the first step to establish the performance characteristics - sensitivity, specificity, positive and negative predictive value - of the imPulse™ Una device for early and rapid, point-of-care diagnosis of COVID-19. This will inform the utility and design of further larger-scale studies using the device.


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date December 2, 2020
Est. primary completion date December 2, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria - Individuals hospitalized within a Johns Hopkins-affiliated hospital - Able to understand and willingness to comply with study procedures - Cases - inpatients with positive COVID-19 PCR test, collected from a respiratory sample within the last 7 days, AND pulmonary symptoms within 72 hours of enrollment - Controls - inpatients without COVID-19 diagnosis 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 Design


Related Conditions & MeSH terms


Intervention

Device:
imPulse™ Una 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.
Philips Lumify Ultrasound System
Point-of-care ultrasound

Locations

Country Name City State
United States Johns Hopkins School of Medicine Baltimore Maryland

Sponsors (3)

Lead Sponsor Collaborator
Level 42 AI, Inc. Johns Hopkins University, Schmidt Futures

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Diagnostic performance characteristics Sensitivity, specificity, positive and negative predictive values - of the imPulse™ Una device for point-of-care diagnosis of COVID-19. through study completion, an average of 2 weeks
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