A Study to Assess the Safety and Efficacy of Pulsenmore ES Home Ultrasound Device in Pregnant Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- PulseNmore
- 入组人数
- 188
- 试验地点
- 7
- 主要终点
- Comparison of device derived presence or absence of fetal cardiac activity to ground truth
研究概览
简要总结
This is a multicenter, prospective, investigational device study designed to evaluate:
The safety, feasibility, and accuracy of the device, when used by pregnant individuals
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 否
入选标准
- •Singleton gestation.
- •Gestational age >14 weeks with a prior scan demonstrating fetal viability and confirming dates.
- •English or Spanish speaking.
- •Ability to understand and sign the informed consent (available in English and Spanish).
- •Ability to read and understand instructions that are required for equipment use (instructions available in both languages).
排除标准
- •Multiple gestations.
- •Known fetal and genetic anomalies.
- •Subjects with skin problems in the abdominal area (such as wounds, cuts in the skin, and skin rash).
- •Subjects allergic to the ultrasound probe materials.
- •Non-English/ non-Spanish speaking.
- •Unable to provide consent.
结局指标
主要结局
Comparison of device derived presence or absence of fetal cardiac activity to ground truth
时间窗: Test to be conducted during week 14-38 of pregnancy
The presence or absence of device derived fetal cardiac activity would be matched with the presence or absence of fetal cardiac activity derived by the ground truth (in-clinic ultrasound scan)
Comparison of device derived amniotic fluid level status, normal or abnormal, to ground truth
时间窗: Test to be conducted during week 14-38 of pregnancy
Comparison of device derived amniotic fluid level status, normal or abnormal, (measured by maximal vertical pocket in cm) would be matched with amniotic fluid level status derived from the ground truth (in-clinic ultrasound scan)
次要结局
- Ability to detect fetal movement from device derived input will be compared to the ground truth(Test to be conducted during week 14-38 of pregnancy)
- Ability to assess placental location from device derived input will be compared to the ground truth(Test to be conducted during week 14-38 of pregnancy)
- Ability to detect fetal breathing from device derived input will be compared to the ground truth(Test to be conducted during week >27-38 of pregnancy)
- Ability to assess fetal presentation from device derived input will be compared to the ground truth(Test to be conducted during week 14-38 of pregnancy)