Feasibility Clinical Investigation Using the InPress Device for the Treatment of Postpartum Hemorrhage
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
- 2
- 主要终点
- Number of Related SAE
研究概览
简要总结
Feasibility trial of the InPress Device to treat postpartum hemorrhage (PPH).
详细描述
10 subjects in first in woman trial with ethics committee oversight. Women who developed postpartum hemorrhage were treated with the InPress Device. The intent of treatment was to quickly reduce or stop blood flow by addressing the driving cause of hemorrhage: uterine atony.
The primary objective is to verify the safety of the InPress Device in humans, including: 1. Absence of SAEs related to the use of the InPress Device intra- and post-procedure. 2. Evaluate any observable damage of the uterus, cervix, or vagina due to the use of the InPress Device. 3. Evaluate occurrence of uterine inversion or folding during the use of the InPress Device.
The secondary objectives include evaluations of: 1. Ability to easily place the InPress Device transvaginally. 2. Ability to connect the InPress Device to vacuum and maintain desired negative pressure. 3. Ability of InPress Device to contract the uterus to a level that reduces or stops blood loss and avoids further surgical intervention. 4. Evaluate time from insertion and start negative pressure to visible reduction of blood loss.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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
- •Subject or her legally authorized representative is able to understand and provide consent to participate in the clinical investigation
- •Female adult subjects (>18 years of age)
- •Subjects who present with an atonic uterus for at least 10 minutes after expulsion of placement with failure to obtain contraction and/or Subjects who have lost blood post-partum >= 500 ml and according to the Investigator's judgment, require an intervention.
排除标准
- •Subjects who do not provide informed consent to participate in the clinical investigation.
- •Subjects who deliver at a uterus size < 34 weeks.
- •Subjects who have lost greater than 1000 ml of blood.
- •Subjects who have abnormal PT, PTT and INR
- •Subjects who present with retained placenta, uterine lacerations, or for any other conditions outside of atonic post-partum hemorrhage.
结局指标
主要结局
Number of Related SAE
时间窗: 6 weeks
Number of device related SAEs
Number of Participants With Damage to Cervix, Uterus or Vagina
时间窗: During the procedure
Number of any observable damage to cervix, uterus, vagina
Number of Participants With Uterine Inversion or Folding
时间窗: During the procedure
Number of uterine inversion or folding during procedure
次要结局
- Time to Uterine Contraction(During the procedure)
- Number of Participants With User Feedback on Placement of InPress(During the procedure)
- Number of Participants With User Feedback on Connection to Vacuum(During the procedure)
- Time(During the procedure)