Safety and Effectiveness of the KOKO Device to Treat Primary Abnormal Postpartum Uterine Bleeding or Hemorrhage

Not Applicable

Recruiting

• Conditions: Hemorrhage, Postpartum; Postpartum Hemorrhage; Immediate Postpartum Hemorrhage
• Interventions: Device: KOKO Device

• Registration Number: NCT06452355
• Lead Sponsor: KOKO Medical Inc.

Brief 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.

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.

Study Timeline

• Study First Submitted: 2024-06-05
• Study First Submitted QC: 2024-06-05
• Study First Posted: 2024-06-11
• Study Start: 2024-08-29
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-07
• Last Update Posted: 2025-04-08
• Primary Completion: 2025-06-30
• Study Completion: 2025-07-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 52

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	KOKO Device	The KOKO device will be administered to participants who are diagnosed with abnormal postpartum uterine bleeding or hemorrhage.

Primary Outcome Measures

Name	Time	Method
Efficacy: Rate of Participants With Cessation of Abnormal Postpartum Uterine Bleeding or Hemorrhaging	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.	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.

Secondary Outcome Measures

Name	Time	Method
Transfusion rate and units	24 Hrs through discharge	Rate of blood product transfusion required after KOKO use, and number of transfusions units administered
Time to control abnormal postpartum uterine bleeding or hemorrhage	24 Hrs	Time from start of treatment to control of bleeding per protocol
KOKO Device Usability	24 Hrs	Clinician reported assessment of KOKO device usability
Rate of non-surgical or surgical procedures after KOKO use	24 Hrs	Rate of non-surgical or surgical procedures required to control abnormal postpartum uterine bleeding or hemorrhage after KOKO use

Trial Locations

Locations (9)

Indiana University School of Medicine, Dept. of OBGYN; 🇺🇸 Indianapolis, Indiana, United States

The Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

University of Alabama; 🇺🇸 Birmingham, Alabama, United States

Christiana Care; 🇺🇸 Newark, Delaware, United States

Ochsner Baptist; 🇺🇸 New Orleans, Louisiana, United States

New York-Presbyterian Hospital (NYPH)/Columbia University Irving Medical Center (CUIMC); 🇺🇸 New York, New York, United States

MetroHealth; 🇺🇸 Cleveland, Ohio, United States

The Ohio State University; 🇺🇸 Columbus, Ohio, United States

University of Utah; 🇺🇸 Salt Lake City, Utah, United States