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Kosmos Anatomical Object Labeling and View Identification Pivotal Study

E

EchoNous

Status

Completed

Conditions

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

Treatments

Device: Kosmos Anatomical Object Labeling and View Identification Algorithms

Study type

Interventional

Funder types

Industry

Identifiers

NCT06468787
ECHO-009

Details and patient eligibility

About

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.

Enrollment

32 patients

Sex

All

Ages

18 to 89 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

32 participants in 1 patient group

Anatomical Object Labeling and View Identification Comparison
Experimental group
Description:
Labeling and identification comparative assessment
Treatment:
Device: Kosmos Anatomical Object Labeling and View Identification Algorithms

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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