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NCT04317521 · ClinicalTrials.gov registry record
: A Prospective Study Investigating the Use of the Eko CORE and Eko DUO Electronic Stethoscopes in Pediatric Patients.
A clinical trial, sponsored by Nemours Children's Clinic.
- Completed
- Registry status
- 315
- Enrollment target
NCT04317521: Completed study, sponsored by Nemours Children's Clinic.
NCT04317521 is a clinical trial that has completed, run by Nemours Children's Clinic. The registered enrollment target is 315 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04317521 has completed, sponsored by Nemours Children's Clinic.
- COMPLETED
- Registry status
- 315 participants
- Enrollment target
Study Summary
The Eko CORE and DUO stethoscopes are FDA approved electronic devices which have the capacity to record heart sounds. This study will utilize these devices to see if they can differentiate between pathologic and innocent heart murmurs in children.
Primary Outcome
The data science team will generate ROC curves for algorithm scores in the set of recorded heart sounds. Exploratory descriptive analyses of the algorithm will be performed by identifying clinical correlates to the characteristics most heavily weighted in detecting a pathologic murmur. The likelihood ratios of the test at sensitivity cut offs of 0.90, 0.95, 0.99 will also be determined. Patients will also be stratified based on age as a secondary outcome: For example, infants (0\<1 years of age
Interventions
- DEVICE Use of EKO Core and EKO Duo electronic stethoscopes
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 315 participants |
| Start Date | 2020-10-24 |
| Est. Completion | 2022-03-11 |
What the finished NCT04317521 record still lists
NCT04317521 is an observational study that tracks outcomes without assigning an intervention. The registered 315 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Use of EKO Core and EKO Duo electronic stethoscopes is the first listed.
NCT04317521 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04317521 about?
NCT04317521 is a clinical study titled ": A Prospective Study Investigating the Use of the Eko CORE and Eko DUO Electronic Stethoscopes in Pediatric Patients.". The Eko CORE and DUO stethoscopes are FDA approved electronic devices which have the capacity to record heart sounds. This study will utilize these devices to see if they can differentiate between pathologic and innocent heart murmurs in children.
What is the current status of trial NCT04317521?
This trial is currently completed. The enrollment target is 315 participants. The study started on 2020-10-24. Estimated completion is 2022-03-11.
What interventions are being tested in trial NCT04317521?
The interventions under investigation include: Use of EKO Core and EKO Duo electronic stethoscopes (DEVICE).
Who is sponsoring clinical trial NCT04317521?
This trial is sponsored by Nemours Children's Clinic, which has 108 total clinical trials registered on ClinicalTrials.gov.
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