Kosmos Anatomical Object Labeling and View Identification Pivotal Study
NCT06468787 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32
Last updated 2024-06-21
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. Algorithm's performance on the view identification task and the object labeling task is computed.
Conditions
- Cardiac Disorder
- Hepatic Disorder
- Spleen Disorder
- Kidney Disorder
- Pulmonary Disorder
- Renal Disorder
- Hepatobiliary Disorders
- GYN Disorders
Interventions
- DEVICE
-
Kosmos Anatomical Object Labeling and View Identification Algorithms
Participants underwent limited ultrasound scanning by both cardiac sonographers and abdominal sonographers. Algorithm's performance on the view identification task and the object labeling task is compared to majority opinion of 5 radiologists.
Sponsors & Collaborators
-
EchoNous Inc.
lead INDUSTRY
Principal Investigators
-
Asad Karim, MD · Revival Research Institute LLC
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 89 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-02-07
- Primary Completion
- 2024-02-22
- Completion
- 2024-02-22
- FDA Device
- Yes
Countries
- United States
Study Locations
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