Mobile, Self-Operated, Home Ultrasound in Pregnancy - Safety, Efficacy and Usability
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- PulseNmore
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Safety - Device related SAE's
研究概览
简要总结
Mobile medical devices for self-patient-use, are a rapidly evolving component of telehealth. Study examines the feasibility of using the INSTINCT® device, a portable self-use ultrasound system attached to a commercial smartphone in remote pregnancy assessment. Study aims to evaluate its safety, efficacy and usability.
详细描述
Study includes women carrying a singleton fetus at 14 to 40 gestational weeks. Women with multiple gestations, non-viable fetus at recruitment and those with a major fetal anatomical malformation or genetic syndrome are excluded. Each participant receives the device for a self-use period of 7-14 days, instructed to preform 1-3 scans a day. Each participant completes a self-assessment questionnaire which aims to evaluate satisfactory and usability (user experience and satisfaction). Each scan will be evaluated for the possibility to properly view fetal heart activity, amniotic fluid volume, fetal tone, fetal body and breathing movements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 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
- •Pregnancy week - 14-
- •Fetus - single, no known genetic or anatomic defects.
- •Able to understand and give informed consent.
排除标准
- •Multiple pregnancy.
- •Known genetic or anatomic defect to the fetus.
- •Inability to understand how to operate the device or give informed
结局指标
主要结局
Safety - Device related SAE's
时间窗: Through study completion until all subject gave birth, an average of 1 year
The device will be deemed safe if all SAE will be classified as not device related
次要结局
- Device Sensitivity level(Through study completion, an average of 1 year)
- Usability rating(Through study completion, an average of 1 year)
- User experience level(Through study completion, an average of 1 year)