Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05176899 |
| Other study ID # |
2021.12 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 11, 2022 |
| Est. completion date |
November 2023 |
Study information
| Verified date |
June 2023 |
| Source |
Eko Devices, Inc. |
| Contact |
Cody Hitchcock, MSc |
| Phone |
1-844-356-3384 |
| Email |
cody.hitchcock[@]ekohealth.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The purpose of this research is to evaluate the impact of Eko AI plus EMAS (Eko Murmur
Analysis Software) on a clinician's referral decision in a real-world primary care setting.
There is an additional objective of understanding patient outcomes when patients are referred
for cardiology follow-up and/or echocardiogram.
Description:
Eko has developed a platform to aid in screening for cardiac conditions using a digital
stethoscope and machine-learning algorithms to detect the presence or absence of heart
conditions such as heart murmurs and atrial fibrillation. In June 2022, the US Food and Drug
Administration (FDA) granted Eko a 510(k) clearance for the marketing of "Eko Murmur Analysis
Software" (EMAS), a set of machine learning algorithms that are able to screen signal quality
and identify fundamental heart sounds, distinguish structural murmurs from absent or innocent
murmurs, and provide a structural murmur's timing in the cardiac cycle.
This study sets out to evaluate the impact of EMAS on a clinician's referral decision in a
real-world primary care setting, with the additional objective of understanding patient
outcomes when patients are referred for cardiology follow-up and/or echocardiogram. Providers
will receive access to the EMAS screening tool, called the SENSORA™ Disease Detection
Platform, which features the FDA cleared 3M™ Littmann® CORE stethoscope paired with the FDA
cleared SENSORA™ enterprise application and EMAS AI running on an iPad, which is mounted on a
Tryten stand. SENSORA™ will be used by medical assistants or equivalent as part of the
initial patient intake process (e.g., during vitals acquisition).
EMAS influence on individual providers will be assessed by reviewing each provider's number
of referrals to cardiology and number of echocardiogram orders for the 6 months preceding
study start. These values will be compared to cardiac referral and order rates at the end of
the study. Patient outcomes data (e.g., cardiology appointment notes, echocardiogram
findings, follow up visits scheduled) will be pulled 6 months after the patient is seen by
their primary care provider. Secondary objectives include the continued assessment of
algorithm performance on a point-of-care population.
