imPulse™ Una Full-spectrum, Over Clothing E-stethoscope

Corona Virus Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04556149
• Other study ID #: 00110011
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Corona Virus Infection
• Coronavirus
• Coronavirus Infections
• Severe Acute Respiratory Syndrome

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