Kosmos Anatomical Object Labeling and View Identification Pivotal Study

Not Applicable

Completed

• Conditions: Pulmonary Disorder; GYN Disorders; Kidney Disorder; Renal Disorder; Spleen Disorder; Cardiac Disorder; Hepatic Disorder; Hepatobiliary Disorders
• Interventions: Device: Kosmos Anatomical Object Labeling and View Identification Algorithms

• Registration Number: NCT06468787
• Lead Sponsor: EchoNous Inc.

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. Algorithm's performance on the view identification task and the object labeling task is computed.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-07
• Primary Completion: 2024-02-22
• Study Completion: 2024-02-22
• Status Verified: 2024-06
• Study First Submitted: 2024-06-06
• Study First Submitted QC: 2024-06-14
• Last Update Submitted: 2024-06-14
• Study First Posted: 2024-06-21
• Last Update Posted: 2024-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Anatomical Object Labeling and View Identification Comparison	Kosmos Anatomical Object Labeling and View Identification Algorithms	Labeling and identification comparative assessment

Primary Outcome Measures

Name	Time	Method
False discovery rate of the anatomical object labeling function on expert-obtained images	Post data acquisition (3 months)	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%.
False discovery rate of the anatomical view identification function on expert-obtained images	Post data acquisition (3 months)	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%.

Trial Locations

Locations (1)

REVIVAL research institute, LLC; 🇺🇸 Sherman, Texas, United States