Clinical Trial Designed to Assess the Safety and Effectiveness of the KOKO™ Device In Treating Primary Abnormal Postpartum Uterine Bleeding ("APUB") or Hemorrhage ("PPH")
概览
- 阶段
- 不适用
- 干预措施
- KOKO Device
- 疾病 / 适应症
- Postpartum Hemorrhage
- 发起方
- KOKO Medical Inc.
- 入组人数
- 72
- 试验地点
- 27
- 主要终点
- Efficacy: Rate of Participants With Cessation of Abnormal Postpartum Uterine Bleeding or Hemorrhaging
- 状态
- 招募中
- 最后更新
- 18天前
概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of the KOKO™ device in the control and reduction of primary abnormal postpartum uterine bleeding or hemorrhage.
详细描述
This IDE study is designed to evaluate the effectiveness and safety of the KOKO™ device to treat primary abnormal postpartum uterine bleeding or hemorrhage. The study is literature controlled.
研究者
入排标准
入选标准
- •Adult Female, 18 years of age or older at time of consent.
- •Subject is able to understand and provide informed consent to participate in the study.
- •Diagnosis of abnormal postpartum uterine bleeding (500 - 999 ml for vaginal birth) or postpartum hemorrhage (1000 - 1500 ml for vaginal or Cesarean birth) with suspected atony within 24 hours after vaginal or cesarean birth.
- •EBL, to be determined when investigator is ready to have the KOKO packaging opened: Vaginal birth: 500 - 1500 ml EBL or Cesarean birth: 1000 - 1500 ml EBL.
- •Failed first - line intervention of uterotonics and uterine massage/bimanual uterine massage to stop bleeding. Note: Uterotonic administration may continue concomitant with and post KOKO use.
排除标准
- •EBL \>1500ml, to be determined when investigator is ready to have the KOKO packaging opened.
- •Delivery at a gestational age \< 34 weeks or, if multiples, uterus is judged \<34 weeks size.
- •For cesarean births: Cervix \< 2.5 cm dilated before use of KOKO.
- •Abnormal postpartum uterine bleeding or hemorrhage that the investigator determines to require more aggressive treatment, including any of the following:
- •hysterectomy;
- •B-lynch suture;
- •uterine artery embolization or ligation;
- •hypogastric ligation.
- •Known uterine anomaly.
- •Ongoing intrauterine pregnancy.
研究组 & 干预措施
Intervention
The KOKO device will be administered to participants who are diagnosed with abnormal postpartum uterine bleeding or hemorrhage.
干预措施: KOKO Device
结局指标
主要结局
Efficacy: Rate of Participants With Cessation of Abnormal Postpartum Uterine Bleeding or Hemorrhaging
时间窗: 24 Hrs
Control of postpartum hemorrhage, defined as the avoidance of non-surgical, second line or surgical intervention to control abnormal postpartum uterine bleeding or hemorrhage after the use of the KOKO device.
Safety: Incidence, 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
- Transfusion rate and units(24 Hrs through discharge)
- Time to control abnormal postpartum uterine bleeding or hemorrhage(24 Hrs)
- KOKO Device Usability(24 Hrs)
- Rate of non-surgical or surgical procedures after KOKO use(24 Hrs)