Data Collection Using Eko Digital Devices in a Clinical Setting

Part of paid clinical trials in Jacksonville, Florida.

Sponsor
Eko Devices, Inc.
Study ID
NCT07227376
Status
Recruiting

Conditions

  • Lung Diseases

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Sep 14, 2025
Status verified
May 2026
Primary completion
Apr 1, 2027
Completion
Nov 30, 2027

Study Design

Enrollment
250 participants (estimated)

Primary Outcome Measure

Primary Objective [ Time Frame: Through study completion, an average of 8-9 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Nemours Children's HealthJacksonvilleFlorida32256
Jackrin Walsh Clinical Research Associate
8443563384
Jefferson Einstein Philadelphia HospitalPhiladelphiaPennsylvania19141-

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