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Data Collection Using Eko Digital Devices in a Clinical Setting

Data Collection Using Eko Digital Devices in a Clinical Setting

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07227376
Enrollment
250
Registered
2025-11-12
Start date
2025-09-14
Completion date
2027-11-30
Last updated
2026-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Diseases

Keywords

lung sounds, adventitious lung sounds, abnormal lung sounds

Brief 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.

Interventions

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

Sponsors

Eko Devices, Inc.
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL

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

Design outcomes

Primary

MeasureTime frameDescription
Primary ObjectiveThrough study completion, an average of 8-9 monthsThe 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.

Countries

United States

Contacts

CONTACTClinical Research Associate
jackrin.walsh@ekohealth.com8443563384

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 27, 2026