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

Completed

• Conditions: Coronavirus; Corona Virus Infection
• Interventions: Device: imPulse™ Una e-stethoscope; Device: Philips Lumify Ultrasound System

• Registration Number: NCT04556149
• Lead Sponsor: Level 42 AI, Inc.

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.

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 Timeline

• Study First Submitted: 2020-05-23
• Study First Submitted QC: 2020-09-15
• Study First Posted: 2020-09-21
• Study Start: 2020-10-01
• Status Verified: 2020-12
• Primary Completion: 2020-12-02
• Study Completion: 2020-12-02
• Last Update Submitted: 2020-12-17
• Last Update Posted: 2020-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Case	Philips Lumify Ultrasound System	Inpatients with confirmed COVID-19 with pulmonary symptoms
Matched Control	imPulse™ Una e-stethoscope	Inpatients without COVID-19 with non-pulmonary diagnoses or symptoms
Case	imPulse™ Una e-stethoscope	Inpatients with confirmed COVID-19 with pulmonary symptoms
Matched Control	Philips Lumify Ultrasound System	Inpatients without COVID-19 with non-pulmonary diagnoses or symptoms

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Johns Hopkins School of Medicine; 🇺🇸 Baltimore, Maryland, United States