NCT07227376 Data Collection Using Eko Digital Devices in a Clinical Setting
| NCT ID | NCT07227376 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Eko Devices, Inc. |
| Condition | Lung Diseases |
| Study Type | OBSERVATIONAL |
| Enrollment | 250 participants |
| Start Date | 2025-09-14 |
| Primary Completion | 2027-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 250 participants in total. It began in 2025-09-14 with a primary completion date of 2027-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07227376 clinical trial?
This trial is open to participants of all sexes, studying Lung Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07227376 currently recruiting?
Yes, NCT07227376 is actively recruiting participants. Contact the research team at jackrin.walsh@ekohealth.com for enrollment information.
Where is the NCT07227376 trial being conducted?
This trial is being conducted at Jacksonville, United States, Philadelphia, United States.
Who is sponsoring the NCT07227376 clinical trial?
NCT07227376 is sponsored by Eko Devices, Inc.. The trial plans to enroll 250 participants.