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

May 8, 2026 updated by: KOKO Medical Inc.

Clinical Trial Designed to Assess the Safety and Effectiveness of the KOKO™ Device In Treating Primary Abnormal Postpartum Uterine Bleeding ("APUB") or Hemorrhage ("PPH")

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Recruiting
        • University Of Alabama
        • Contact:
        • Principal Investigator:
          • Deepti Sharma, MD
    • Delaware
      • Newark, Delaware, United States, 19718
        • Recruiting
        • Christiana Care
        • Contact:
        • Principal Investigator:
          • Matthew Hoffman, FACOG MD MPH
    • Florida
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami
        • Principal Investigator:
          • Michael Paidas, MD
        • Contact:
        • Principal Investigator:
          • Gelila Goba, MD
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University School of Medicine, Dept. of OBGYN
        • Principal Investigator:
          • Christina Scifres, MD
        • Contact:
        • Principal Investigator:
          • Emily Cassell, MD
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Recruiting
        • University of Kentucky
        • Contact:
        • Principal Investigator:
          • John M O'Brien, MD
    • Louisiana
      • New Orleans, Louisiana, United States, 70115
        • Withdrawn
        • Ochsner Baptist
      • Shreveport, Louisiana, United States, 71103
        • Recruiting
        • LSU Heath Sciences Center - Shreveport
        • Contact:
        • Principal Investigator:
          • Caitlin Busada, MD
    • Nevada
      • Las Vegas, Nevada, United States, 89109
        • Recruiting
        • Sunrise Hospital and Medical Center
        • Principal Investigator:
          • Brian Iriye, MD
        • Contact:
    • New York
      • Flushing, New York, United States, 11355
        • Recruiting
        • New York-Presbyterian Medical Group Queens
        • Principal Investigator:
          • Daniel Skupski, MD
        • Contact:
      • New York, New York, United States, 10032
        • Recruiting
        • New York-Presbyterian Hospital (NYPH)/Columbia University Irving Medical Center (CUIMC)
        • Contact:
        • Principal Investigator:
          • Dena Goffman, MD
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Recruiting
        • Duke University
        • Contact:
        • Principal Investigator:
          • Jerome Federspiel, MD
    • Ohio
      • Cleveland, Ohio, United States, 44109
        • Recruiting
        • MetroHealth
        • Principal Investigator:
          • Kelly Gibson, MD
        • Contact:
      • Cleveland, Ohio, United States, 44111
        • Recruiting
        • The Cleveland Clinic
        • Contact:
        • Principal Investigator:
          • Maeve Hopkins, MD
      • Columbus, Ohio, United States, 43210
        • Active, not recruiting
        • The Ohio State University
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
        • Contact:
        • Principal Investigator:
          • Eliza McElwee, MD
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • Baylor College of Medicine
        • Contact:
        • Principal Investigator:
          • Catherine Epps, MD
      • Houston, Texas, United States, 77030
        • Recruiting
        • UT Health Houston
        • Contact:
        • Principal Investigator:
          • Megan Shepherd, MD
      • San Antonio, Texas, United States, 78229
        • Not yet recruiting
        • UT Health San Antonio
        • Contact:
        • Principal Investigator:
          • Patrick Ramsey, MD
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • Recruiting
        • University of Utah
        • Principal Investigator:
          • Marcela Smid, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
The KOKO device will be administered to participants who are diagnosed with abnormal postpartum uterine bleeding or hemorrhage.
Device: KOKO 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy: Rate of Participants With Cessation of Abnormal Postpartum Uterine Bleeding or Hemorrhaging
Time Frame: 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.
24 Hrs
Safety: Incidence, Severity and Seriousness of Device-related Adverse Events Experienced by Participants.
Time Frame: 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.
6 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

KOKO Medical Inc.

Investigators

  • Principal Investigator: Dena Goffman, MD, Columbia University
  • Principal Investigator: Brian Iriye, MD, Sunrise Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 29, 2024

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

June 5, 2024

First Submitted That Met QC Criteria

June 5, 2024

First Posted (Actual)

June 11, 2024

Study Record Updates

Last Update Posted (Actual)

May 13, 2026

Last Update Submitted That Met QC Criteria

May 8, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KOKO-PPH-001 (PSD-10212)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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