Kosmos Anatomical Object Labeling and View Identification Pivotal Study

NCT06468787 | Completed FDA Device

• 1 other identifier: ECHO-009
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Disorder; Hepatic Disorder; Spleen Disorder; Kidney Disorder; Pulmonary Disorder; Renal Disorder; Hepatobiliary Disorders; GYN Disorders

Outcome Measures

Primary Outcomes (2)

• 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)

Study Arms (1)

Anatomical Object Labeling and View Identification Comparison

EXPERIMENTAL

Labeling and identification comparative assessment

Device: Kosmos Anatomical Object Labeling and View Identification Algorithms

Interventions

Kosmos Anatomical Object Labeling and View Identification Algorithms DEVICE

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.

Anatomical Object Labeling and View Identification Comparison

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• EchoNous Inc.: lead

Study Sites (1)

REVIVAL research institute, LLC

Sherman, Texas, 75092, United States

Location

MeSH Terms

Conditions

Heart Diseases; Digestive System Diseases; Splenic Diseases; Kidney Diseases; Lung Diseases; Genital Diseases, Female

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Lymphatic Diseases; Hemic and Lymphatic Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Respiratory Tract Diseases; Genital Diseases

Study Officials

• Asad Karim, MD

  Revival Research Institute LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2024
• First Posted: June 21, 2024
• Study Start: February 7, 2024
• Primary Completion: February 22, 2024
• Study Completion: February 22, 2024
• Last Updated: June 21, 2024

Record last verified: 2024-06

Locations

US (1)