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

Sponsor

Level 42 AI, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT04556149

Collaborator

Schmidt Futures (Other), Johns Hopkins University (Other)

Enrollment

Location

Actual Duration (Months)

16.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Corona Virus Infection Coronavirus	Device: imPulse™ Una e-stethoscope Device: Philips Lumify Ultrasound System

Detailed 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.

Study Design

Study Type:

Observational

Actual Enrollment :

34 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Oct 1, 2020

Actual Primary Completion Date :

Dec 2, 2020

Actual Study Completion Date :

Dec 2, 2020

Arms and Interventions

Arm	Intervention/Treatment
Case Inpatients with confirmed COVID-19 with pulmonary symptoms	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. Device: Philips Lumify Ultrasound System Point-of-care ultrasound
Matched Control Inpatients without COVID-19 with non-pulmonary diagnoses or symptoms	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. Device: Philips Lumify Ultrasound System Point-of-care ultrasound

Arm

Intervention/Treatment

Case

Inpatients with confirmed COVID-19 with pulmonary symptoms

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.

Device: Philips Lumify Ultrasound System

Point-of-care ultrasound

Matched Control

Inpatients without COVID-19 with non-pulmonary diagnoses or symptoms

Device: imPulse™ Una e-stethoscope

Device: Philips Lumify Ultrasound System

Point-of-care ultrasound

Outcome Measures

Primary Outcome Measures

Diagnostic performance characteristics [through study completion, an average of 2 weeks]
Sensitivity, specificity, positive and negative predictive values - of the imPulse™ Una device for point-of-care diagnosis of COVID-19.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Johns Hopkins School of Medicine	Baltimore	Maryland	United States	21287-5554

Sponsors and Collaborators

Level 42 AI, Inc.
Schmidt Futures
Johns Hopkins University

Investigators

Principal Investigator: Kelly Dooley, MD, PhD, Johns Hopkins School of Medicine
Study Director: Ed Fuchs, MBA, Johns Hopkins School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Level 42 AI, Inc.

ClinicalTrials.gov Identifier:

NCT04556149

Other Study ID Numbers:

00110011

First Posted:

Sep 21, 2020

Last Update Posted:

Dec 21, 2020

Last Verified:

Dec 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Level 42 AI, Inc.

Additional relevant MeSH terms:

Coronavirus Infections

Study Results

No Results Posted as of Dec 21, 2020