Clinical trial NCT06468787: Kosmos Anatomical Object Labeling and View Identification Pivotal Study
Official title: ECHO-009 Kosmos Anatomical Object Labeling and View Identification Pivotal Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Disorder
Hepatic Disorder
Spleen Disorder
Kidney Disorder
Pulmonary Disorder
Renal Disorder
Hepatobiliary Disorders
GYN Disorders
Lead sponsor: EchoNous Inc.
Sponsor class: INDUSTRY
First posted: 2024-06-21
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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.

Primary outcomes:
measure: False discovery rate of the anatomical object labeling function on expert-obtained images
timeFrame: Post data acquisition (3 months)
measure: False discovery rate of the anatomical view identification function on expert-obtained images
timeFrame: Post data acquisition (3 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Sherman
country: United States
facility: REVIVAL research institute, LLC
state: Texas
Study officials:
affiliation: Revival Research Institute LLC
name: Asad Karim, MD
role: PRINCIPAL_INVESTIGATOR
References: