Clinical Trial Designed to Assess the Safety and Effectiveness of the KOKO™ Device In Treating Primary Abnormal Postpartum Uterine Bleeding ("APUB") or Hemorrhage ("PPH")
KOKO Medical Inc.
Summary
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.
Description
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.
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * 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 utero…
Interventions
- DeviceKOKO Device
The intrauterine drain is extended into the uterus, where low pressure vacuum is applied to the uterus through the fabric intrauterine drain. The KOKO™ device utilizes this vacuum to remove excess blood and compress the uterus reducing further blood loss.
Locations (19)
- University of AlabamaBirmingham, Alabama
- Christiana CareNewark, Delaware
- University of MiamiMiami, Florida
- Indiana University School of Medicine, Dept. of OBGYNIndianapolis, Indiana
- University of KentuckyLexington, Kentucky
- Ochsner BaptistNew Orleans, Louisiana