Optimization of an Automated Ultrasound Cardiac Guidance Tool
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- ACCURACY- Optimization of an automated ultrasound cardiac guidance tool.
研究概览
简要总结
Open-label, single-arm, prospective study. Subjects will undergo one session of 2D Transthoracic Echocardiogram (2D-TTE) ultrasound. The ultrasound will be performed by a trained sonographer.
详细描述
The study will use a commercially available handheld imaging device (Philips Lumify transducer).
Primary Objective:
To acquire images of multiple transducer position, trajectories, and views, at different acoustic windows for capturing images and location relative to body and probe positions.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years and above.
- •Patients able to understand, read and sign the informed consent
- •Patient willing to answer a short questionnaire
排除标准
- •Pregnancy(females of childbearing potential will be tested with a urine pregnancy test prior to their inclusion in the study)
- •Not willing or not able to sign an inform consent
- •Physical limitation to maneuvering the probe on the body
- •Unable to lie flat for study
- •Patients experiencing a known or suspected acute cardiac event
- •Patients with severe chest wall abnormalities
- •Patients who have undergone pneumonectomy
- •Patients whose anatomy does not lend itself to echocardiography
结局指标
主要结局
ACCURACY- Optimization of an automated ultrasound cardiac guidance tool.
时间窗: 1 year
To acquire images from different transducer positions, trajectories, and views, at different acoustic windows for capturing images and location relative to body and probe. This study is designed to capture data for the training of the UltraSight Guidance software AI models. The obtained data will not be anlyzed for statistical purposes but will only be used for the algorithm development based on the technician movements recording, with no reference to images quality or medical utilization.
次要结局
未报告次要终点