Ignite Creation Date:
2024-07-17 @ 11:17 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06468787
Status:
COMPLETED
Last Update Posted:
2024-06-21
First Post:
2024-06-06
Brief Title:
Kosmos Anatomical Object Labeling and View Identification Pivotal Study
Sponsor:
EchoNous Inc
Organization:
EchoNous Inc
Study Overview
Official Title:
ECHO-009 Kosmos Anatomical Object Labeling and View Identification Pivotal Study
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a multi-site multi-group study that obtained two sets of ultrasound scans from all enrolled participants Participants underwent limited ultrasound scanning by both cardiac sonographers and abdominal sonographers Algorithms performance on the view identification task and the object labeling task is computed
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None