Kosmos Anatomical Object Labeling and View Identification Pivotal Study

ECHO-009 Kosmos Anatomical Object Labeling and View Identification Pivotal Study

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.

Study Overview

• Status: Completed
• Conditions: Kidney Disorder; GYN Disorders; Hepatobiliary Disorders; Cardiac Disorder; Renal Disorder; Hepatic Disorder; Spleen Disorder; Pulmonary Disorder
• Intervention / Treatment: Device: Kosmos Anatomical Object Labeling and View Identification Algorithms

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Sherman, Texas, United States, 75092
      • Revival Research Institute, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Persons able to:
• Read and sign an English consent form.
• Give consent for participation.
• Able and willing to comply with study requirements.
• Those aged 18 years through 89 years, healthy as well as individuals with pathology, including but not limited to:
• Persons with heart-related conditions such as myocardial or pericardial disease.
• Persons with lung-related conditions such as: asthma, COPD, bronchitis, pulmonary fibrosis, sarcoidosis, pulmonary hypertension, pulmonary hypertension, bronchiectasis, lung cancer, pneumonia, pulmonary edema, pulmonary embolism
• Persons with abdomen-related conditions such as: pancreatitis, gastroesophageal reflux disease, irritable bowel syndrome, colitis, gastroenteritis, ulcers, abdominal aortic aneurysm, splenomegaly, liver disease, kidney disease.

Exclusion Criteria:

• Children (minors) under 18 years old
• Adults over 89 years old
• Pregnant individuals
• Those who cannot or refuse to sign their consent
• Those who cannot provide informed consent
• Those who cannot speak or read English
• Vulnerable populations, i.e., individuals whose willingness to participate in the study could be unduly influenced by the expectation of medical benefits associated with participation
• Individuals with mobility issues that prevent them from having an echo examination
• Individuals with severe chest deformities, or other critical clinical situations, e.g., life critical urgent situations where there is no time for anything else than what is needed for patient care, that prevent them from having an echo examination.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Anatomical Object Labeling and View Identification Comparison; Labeling and identification comparative assessment	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
False discovery rate of the anatomical object labeling function on expert-obtained images	The objective of this study is to compare the average frame-level disagreement of object labeling by majority opinion of five expert reviewers. The frame-level disagreement is defined as False Discovery Rate as in (1) FDR = 1-Precision=FP/(FP+TP) (1) Where TP≡True Positive and FP≡False Positive. A True Positive is counted when the majority opinion of five expert reviewers agrees with the location of predicted labels in the image. A False Positive counted when majority opinion of five expert reviewers disagrees with the location of one or more predicted labels. False Discovery Rate (FDR) is measured for a particular image frame between predicted objects and the majority opinion of five reviewers. The frame-level FDR threshold for this prospective study is 20%. Therefore, for a successful outcome the frame-level FDR must be less than 20%.	Post data acquisition (3 months)
False discovery rate of the anatomical view identification function on expert-obtained images	The objective of this study is to compare the average frame-level disagreement of object labeling by majority opinion of five expert reviewers. The frame-level disagreement is defined as False Discovery Rate as in (1) FDR = 1-Precision=FP/(FP+TP) (1) Where TP≡True Positive and FP≡False Positive. A True Positive is counted when the majority opinion of five expert reviewers agrees with the location of predicted labels in the image. A False Positive counted when majority opinion of five expert reviewers disagrees with the location of one or more predicted labels. False Discovery Rate (FDR) is measured for a particular image frame between predicted objects and the majority opinion of five reviewers. The frame-level FDR threshold for this prospective study is 20%. Therefore, for a successful outcome the frame-level FDR must be less than 20%.	Post data acquisition (3 months)

Collaborators and Investigators

• Sponsor: EchoNous Inc.
• Investigators: Principal Investigator: Asad Karim, MD, Revival Research Institute LLC

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2024
• Primary Completion (Actual): February 22, 2024
• Study Completion (Actual): February 22, 2024

Study Registration Dates

• First Submitted: June 6, 2024
• First Submitted That Met QC Criteria: June 14, 2024
• First Posted (Actual): June 21, 2024

Study Record Updates

• Last Update Posted (Actual): June 21, 2024
• Last Update Submitted That Met QC Criteria: June 14, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Respiratory Tract Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Liver Diseases; Heart Diseases; Kidney Diseases; Lung Diseases; Digestive System Diseases
• Other Study ID Numbers: ECHO-009

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes