Prospective Clinical Data Collection for Developing Machine Learning-assisted Obstetric Ultrasound (MOBUS) Screening Algorithms
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 700
- 试验地点
- 4
- 主要终点
- Research sweep Ultrasound Images (Vscan ) from the participants will be assessed for quality of images and comparing with patient chart history
研究概览
简要总结
The goal of this clinical trial is to
- Collect ultrasound data from pregnant and non-pregnant individuals presenting to multiple study sites.
- Use the collected data and ultrasound images to train and validate Artificial intelligence algorithms developed by the Sponsor
Consented participants will be asked to take part in a research ultrasound scan
详细描述
In this study pregnant and no pregnant subjects will be recruited from Obstetrics and Gynecology clinics/hospitals or from Maternal and Fetal Medicine centers. The pregnant subjects will be in Group 1 and non pregnant subjects will be in Group 2. Pregnant subjects are only recruited if they are scheduled for an obstetric standard of care scan . Both the group will undergo research scan, which is a sweep protocol using handheld FDA approved ultrasound device like Vscan. Patient chart history (no PHI), standard of care scan ultrasound images (no PHI), and research scan ultrasound images (no PHI) would be obtained from Group 1 subjects. Patient history (no PHI), research ultrasound images (no PHI) would be obtained from Group 2 subjects The data collected from this study will be used by the sponsor to develop algorithms for screening various fetal health parameters such as gestational age, placenta location, fetal heart rate, number of fetuses, fetal positions etc
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研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant group (Group 1)
- •Participants aged 18 years or older at time of consent.
- •Participants with confirmed pregnancy (positive HCG urine test strip and/or a documented obstetric ultrasound scan.
- •Participants who are scheduled for or referred for a standard-of-care clinical obstetric ultrasound examination.
- •Participants who provide written consent.
- •Non-pregnant group (Group 2)
- •Participants aged 18 years or older at time of consent.
- •Participants who are not actively pregnant (confirmed using an HCG urine test strip).
- •Participants who provide written informed consent.
排除标准
- •Participants for whom participating in this study would delay or compromise care in any way.
- •Participants who are not able to understand or provide written consent.
结局指标
主要结局
Research sweep Ultrasound Images (Vscan ) from the participants will be assessed for quality of images and comparing with patient chart history
时间窗: 9 months
All the participant's research ultrasound image will be obtained. This image will be checked for image quality on various stages of pregnancy as well as for non pregnant subjects. These images will be used to develop algorithms for measuring gestational age, placenta location etc.
次要结局
未报告次要终点