Fetal Heart Ultrasound Imaging – Prospective data collection of normal and abnormal cases
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- 100 subjects with data validated by the sponsor have been enrolled at each site (including 10 abnormal fetal hearts) or we have reached a number of samples that have allowed the development of algorithms sufficiently accurate to be tested in a validation study.
研究概览
简要总结
| This study is a prospective data collection study. |
The main objective of the study is to collect DICOM ultrasound imaging data in 200 fetuses with normal or abnormal fetal heart to design and develop algorithms for automated/semi-automated fetal heart ultrasound assessment.
The data collection will be done at two independent clinical sites with non-competitive recruitment (100 subjects total at each centre including 10 abnormal fetal hearts). Both centres: Mediscan systems, Chennai and Thane Ultrasound centre, Mumbai, are referral diagnostic ultrasound centres in India.
Data collection will be done on the commercial registered ultrasound devices of the centre (Philips Affiniti 70, Philips Epiq 5 or 7) and one commercially released ultrasound device from the sponsor (Philips Affiniti 70 at Mediscan systems only) and will be used within the intended use.
The end-point of the study will be reached when the data from the 200 ultrasound scans has been collected and transferred to the Sponsor after de-identification.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- Female
入选标准
- •Female patients, aged 18 years or more, presenting for a routine or referred US scan with: A pregnancy equal or above 17 weeks of gestation Singleton pregnancy or multiple pregnancy Normal pregnancy or abnormal pregnancy (maternal or fetal conditions) Willing and able to provide informed consent.
排除标准
- •Subject aged below 18 years.
- •Subject with a pregnancy younger than 17 weeks.
- •Subjects (mothers) presenting with fever or hemorrhagia or any condition that needs emergency care (as per investigator’s discretion).
- •Subject (mother) with neurological or psychiatric disorders or other disorders that affect the subject’s understanding of the information provided with the consent form.
- •Subject unwilling or unable to provide informed consent.
结局指标
主要结局
100 subjects with data validated by the sponsor have been enrolled at each site (including 10 abnormal fetal hearts) or we have reached a number of samples that have allowed the development of algorithms sufficiently accurate to be tested in a validation study.
时间窗: Estimated completion date: 28th February 2019
次要结局
未报告次要终点