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Recruiting Observational

Data Collection Using Eko Digital Devices in a Clinical Setting

NCT07227376 · tracked via the Priya Life Science USA tracker
Phase
Observational
Started
2025-09-14
Last updated
2026-05-26

Condition(s) studied

Lung Diseases

Investigational drug(s) / intervention(s)

Eko digital stethoscopes

Eko digital stethoscopes: Use of the Eko CORE 500 digital stethoscope and 3M Littmann CORE Digital Stethoscope to listen for and record lung sounds.

Study summary

The purpose of this research is to prospectively train and validate an artificial intelligence machine learning (ML) algorithm to detect the presence of adventitious lung sounds in adults. Clinicians will use the Eko CORE and/or Eko CORE 500 device(s) in real clinical settings to collect normal and abnormal lung sounds, as part of standard of care clinical practice, which will then be used to explore an ML algorithm for classifiers for wheeze, coarse crackle, fine crackle, rhonchus, stridor, rales, and cough, as well as determine any correspondences between the type and/or location of adventitious lung sounds and the type of pulmonary conditions as reported by clinicians.

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Suspected or diagnosed lower respiratory condition OR Presence of wheeze, coarse crackle, fine crackle, rhonchus, stridor, rales, and cough discovered during routine auscultation * Normal patients with no adventitious lung sounds * Adults and pediatric patients (as available) Exclusion Criteria: * Unable to have multiple recordings taken on chest and back (e.g. compromised mobility) * On mechanical ventilation

Primary outcome measure(s)

  • Primary Objective — Through study completion, an average of 8-9 months
    The primary objective of this study is to collect normal and abnormal lung sounds of up to 750 patients per study site, by having clinicians use the Eko CORE and/or Eko CORE 500 device(s) in real clinical settings, as part of standard of care clinical practice which will then be used to explore an ML algorithm for classifiers for wheeze, coarse crackle, fine crackle, rhonchus, stridor, rales, and cough, as well as determine any correspondences between the type and/or location of adventitious lung sounds and the type of pulmonary conditions as reported by clinicians.

Trial sites (2)

FacilityCityRegionStatus
Nemours Children's Health Jacksonville Florida Recruiting
Jefferson Einstein Philadelphia Hospital Philadelphia Pennsylvania Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07227376 on ClinicalTrials.gov ↗ ← All trials in the USA