KIRA Uterine Drain Device Evaluation - First-In- Human Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Incidence, severity and seriousness of device related Adverse Events (ADE's)
研究概览
简要总结
The purpose of this research is to evaluate a new investigational medical device, the Kira device, intended to make it easier for the surgical team to monitor blood loss during and immediately after cesarean deliveries (c-sections). This study will assess the safety of the device and the device's ability to gently suction blood from the uterus into a clear container where it can be seen and measured by the surgical team.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •Adult, sex female at birth, age 18 years or older at the time of consent.
- •Able to understand and provide informed consent to participate in the study.
- •Undergoing c-section
排除标准
- •Ongoing intrauterine pregnancy
- •Untreated uterine rupture
- •Unresolved uterine inversion
- •Known uterine, cervical, or vaginal anomaly that would prohibit device placement.
- •Placenta abnormality including a) known placenta accreta, b) retained placenta with known risk factors for placenta accreta (e.g. history of prior uterine surgery, including prior c-section and placenta previa), c) retained placenta without easy manual removal.
- •Diagnosis of coagulopathy
- •Current cervical cancer
- •Current purulent infection of vagina, cervix or uterus.
- •History of allergy to device materials (thermoplastic elastomers (TPE), acrylonitirile butadiene styrene plastic (ABS), cyanoacrylate)
- •Lack of study consent
研究组 & 干预措施
Interventional
All participants will be assigned to the interventional arm, in which the uterine drain is used to evaluate the blood loss immediately following cesarean delivery.
干预措施: Uterine drain for use in cesarean section (Device)
结局指标
主要结局
Incidence, severity and seriousness of device related Adverse Events (ADE's)
时间窗: Measured at study exit, approximately 3 days
次要结局
- Ease of use questionnaire(Within 2 weeks of study completion)
- Cumulative blood loss(Measured through 24 hours from time of delivery)