Safety and Effectiveness of the KOKO Device to Treat Primary Abnormal Postpartum Uterine Bleeding or Hemorrhage
Purpose
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.
Conditions
- Postpartum Hemorrhage
- Immediate Postpartum Hemorrhage
- Hemorrhage, Postpartum
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- Female
- Accepts 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 uterotonics and uterine massage/bimanual uterine massage to stop bleeding. Note: Uterotonic administration may continue concomitant with and post KOKO use.
Exclusion Criteria
- 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: 1. hysterectomy; 2. B-lynch suture; 3. uterine artery embolization or ligation; 4. hypogastric ligation. - Known uterine anomaly. - Ongoing intrauterine pregnancy. - Placental abnormality including any of the following: 1. known placenta accreta; 2. retained placenta with known risk factors for placenta accreta (e.g., history of prior uterine surgery, including prior cesarean and placenta previa); 3. retained placenta without easy manual removal. - Known uterine rupture. - Unresolved uterine inversion. - Subject has undergone intrauterine balloon therapy, uterine packing or use of other negative pressure system(s) for tamponade treatment of this episode of abnormal postpartum uterine bleeding or hemorrhage prior to use of the KOKO™ device. - Current cervical cancer. - Current purulent infection of vagina, cervix, uterus. - Diagnosis of coagulopathy.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- Phase A is considered a Pilot Study during which 20 subjects were enrolled. Phase B will enroll up to 52 additional subjects.
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Intervention |
The KOKO device will be administered to participants who are diagnosed with abnormal postpartum uterine bleeding or hemorrhage. |
|
Recruiting Locations
University of Alabama
Birmingham 4049979, Alabama 4829764 35233
Birmingham 4049979, Alabama 4829764 35233
Christiana Care
Newark 4143861, Delaware 4142224 19718
Newark 4143861, Delaware 4142224 19718
University of Miami
Miami 4164138, Florida 4155751 33136
Miami 4164138, Florida 4155751 33136
Indiana University School of Medicine, Dept. of OBGYN
Indianapolis 4259418, Indiana 4921868 46202
Indianapolis 4259418, Indiana 4921868 46202
LSU Heath Sciences Center - Shreveport
Shreveport 4341513, Louisiana 4331987 71103
Shreveport 4341513, Louisiana 4331987 71103
Sunrise Hospital and Medical Center
Las Vegas 5506956, Nevada 5509151 89109
Las Vegas 5506956, Nevada 5509151 89109
New York-Presbyterian Hospital (NYPH)/Columbia University Irving Medical Center (CUIMC)
New York 5128581, New York 5128638 10032
New York 5128581, New York 5128638 10032
MetroHealth
Cleveland 5150529, Ohio 5165418 44109
Cleveland 5150529, Ohio 5165418 44109
The Ohio State University
Columbus 4509177, Ohio 5165418 43210
Columbus 4509177, Ohio 5165418 43210
University of Utah
Salt Lake City 5780993, Utah 5549030 84132
Salt Lake City 5780993, Utah 5549030 84132
More Details
- NCT ID
- NCT06452355
- Status
- Recruiting
- Sponsor
- KOKO Medical Inc.
Detailed 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.