ECHO-009 Kosmos Anatomical Object Labeling and View Identification Pivotal Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- False discovery rate of the anatomical object labeling function on expert-obtained images
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
False discovery rate of the anatomical object labeling function on expert-obtained images
时间窗: 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
时间窗: 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%.
次要结局
未报告次要终点