Prospective, Single Arm Pivotal Clinical Trial Designed to Assess the Safety and Effectiveness of the Jada System in Treating Primary Postpartum Hemorrhage
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 107
- 试验地点
- 15
- 主要终点
- Efficacy: Rate of Participants With Cessation of Uterine Hemorrhaging
研究概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of the Jada System in the control and reduction of primary postpartum hemorrhage.
详细描述
This IDE study is designed to evaluate the effectiveness and safety of the Jada System to treat primary PPH. The study is literature controlled.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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 Female, 18 years of age or older at time of consent.
- •Able to understand and provide informed consent to participate in the study.
- •Diagnosis of PPH with suspected atony within 24 hours after vaginal or c-section delivery.
- •EBL, to be determined when investigator is ready to have Jada peel pack opened: a) vaginal delivery: 500 - 1500 ml EBL or b) c-section delivery: 1000 - 1500 ml EBL.
- •Failed first-line intervention of uterotonics and uterine massage/bimanual compression to stop bleeding. Note: Uterotonic administration may continue concomitant with and post Jada use.
排除标准
- •EBL > 1500 ml, to be determined when investigator is ready to have the Jada peel pack opened.
- •Delivery at a gestational age < 34 weeks.
- •For C-sections: Cervix < 3 cm dilated before Jada use.
- •PPH that the investigator determines to require more aggressive treatment, including any of the following: a) hysterectomy, b) b-lynch suture, c) uterine artery embolization or ligation, d) hypogastric ligation.
- •Known uterine anomaly.
- •Ongoing intrauterine pregnancy.
- •Placenta abnormality including any of the following: 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.
- •Known uterine rupture.
- •Unresolved uterine inversion.
- •Subject has undergone intrauterine balloon therapy or uterine packing for tamponade treatment of this PPH prior to use of the Jada.
- •Current cervical cancer.
- •Current purulent infection of the vagina, cervix, uterus.
- •Diagnosis of coagulopathy.
研究组 & 干预措施
Intervention
Jada System for Postpartum Hemorrhage will be administered to subjects who are diagnosed with postpartum hemorrhage.
干预措施: Jada System (Device)
结局指标
主要结局
Efficacy: Rate of Participants With Cessation of Uterine Hemorrhaging
时间窗: 24 hrs
Control of postpartum hemorrhage, defined as the avoidance of non-surgical, second-line or surgical intervention to control uterine hemorrhage after the use of the Jada System per the Instructions for Use
Safety: Incidence (i.e., Rate or Number of Participants), Severity and Seriousness of Device-related Adverse Events Experienced by Participants
时间窗: 6 weeks
Incidence (i.e., rate or number of participants), severity and seriousness of device-related Adverse Events experienced by participants will be documented during the course of the study.
次要结局
未报告次要终点