Trials / Completed
CompletedNCT06027164
Kosmos Trio and Ejection Fraction Pivotal Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 153 (actual)
- Sponsor
- EchoNous Inc. · Industry
- Sex
- All
- Age
- 18 Years – 89 Years
- Healthy volunteers
- Accepted
Summary
This is a single-group, observational study which will involve obtaining two echo scans of recruited patients. All recruited patients will undergo echo scans by both novice users (nurses) and experts (echo sonographers). Image quality between novices and experts as well as the ability to calculate LVEF from novice and expert scans and the quality of the LVEF calculated via KOSMOS-EF compared to LVEF calculations by expert cardiologists will occur in post-hoc Echo image analysis
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Portable Ultrasound System | EchoNous KOSMOS |
Timeline
- Start date
- 2023-08-04
- Primary completion
- 2023-08-31
- Completion
- 2024-05-16
- First posted
- 2023-09-07
- Last updated
- 2024-05-21
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06027164. Inclusion in this directory is not an endorsement.