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Data Collection Using Eko 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
NCT07270744
Enrollment
200
Registered
2025-12-08
Start date
2025-10-01
Completion date
2026-12-31
Last updated
2026-09-01

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 main objectives of the study are to: train and validate binary classifiers for wheeze, coarse crackle, fine crackle, rhonchus, stridor, rales, and cough, as well as determine correspondence between type/location of adventitious lung sound and type of pulmonary condition.

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
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Patients 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 patients, over 18 years old * Able to provide verbal consent

Exclusion criteria

* Patients unable to have multiple recordings taken on chest and back (e.g. compromised mobility) * Patients on mechanical ventilation * Patients unwilling or unable to provide informed consent

Design outcomes

Primary

MeasureTime frameDescription
Primary Objective: Collection of Lung Sound Recordings to Explore Machine Learning Algorithm for Classifying Adventitious Lung Sounds14-15 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.

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 2, 2026