Recruiting

Artificial Intelligence

Sponsor:

Eko Devices, Inc.

Code:

NCT07227376

Conditions

Lung Diseases

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Eko digital stethoscopes

Study Details

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.

Conditions

Lung Diseases

Study ID

NCT07227376

Start date

Sep 14, 2025

Status verified date

May, 2026

Completion date

Nov 30, 2027

Anticipated

Primary completion date

Apr 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

250 participants

Anticipated

Interventions and Outcome Measures

Interventions

Eko digital stethoscopes

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Clinical Research Associate

8443563384jackrin.walsh@ekohealth.com

Locations

Nemours Children's Health

Recruiting

Jacksonville, Florida, United States, 32256

Contacts

Jackrin Walsh Clinical Research Associate

8443563384jackrin.walsh@ekohealth.com

Jefferson Einstein Philadelphia Hospital

Recruiting

Philadelphia, Pennsylvania, United States, 19141

More Information

Sponsor

Eko Devices, Inc.

Last update posted

May 26, 2026

Last verified

May, 2026

Keywords

  • lung sounds
  • adventitious lung sounds
  • abnormal lung sounds

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Eko Devices, Inc. on 2026-05-26.