Kosmos Anatomical Object Labeling and View Identification Pivotal Study

GYN Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06468787
• Other study ID #: ECHO-009
• Status: Completed
• Phase: N/A
• Start date: February 7, 2024
• Est. completion date: February 22, 2024

Study information

• Verified date: June 2024
• Source: EchoNous Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: February 22, 2024
• Est. primary completion date: February 22, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiac Disorder
• Digestive System Diseases
• GYN Disorders
• Heart Diseases
• Hepatobiliary Disorders
• Kidney Diseases
• Liver Diseases
• Lung Diseases
• Renal Disorder

Intervention

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.

Locations

Country	Name	City	State
United States	REVIVAL research institute, LLC	Sherman	Texas

Sponsors (1)

Lead Sponsor	Collaborator
EchoNous Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)