RecruitingNCT07227376

Data Collection Using Eko Digital Devices in a Clinical Setting


Sponsor

Eko Devices, Inc.

Enrollment

250 participants

Start Date

Sep 14, 2025

Study Type

OBSERVATIONAL

Conditions

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

Inclusion Criteria3

  • 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 Criteria2

  • Unable to have multiple recordings taken on chest and back (e.g. compromised mobility)
  • On mechanical ventilation

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Interventions

DEVICEEko digital stethoscopes

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


Locations(2)

Nemours Children's Health

Jacksonville, Florida, United States

Jefferson Einstein Philadelphia Hospital

Philadelphia, Pennsylvania, United States

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NCT07227376


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