Kosmos Anatomical Object Labeling and View Identification Pivotal Study

NCT06468787 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2024-06-21

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06468787 on ClinicalTrials.gov