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New vacuum device aims to stop postpartum bleeding without surgery

NCT ID NCT06452355

Disease control Sponsor: KOKO Medical Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 26, 2026 · Updated 3 times

Summary

This study tests a device called KOKO, which uses gentle suction inside the uterus to remove excess blood and help the uterus contract, stopping heavy bleeding after childbirth. About 72 women who experience significant blood loss within 24 hours of delivery will be enrolled. The goal is to see if the device can control bleeding safely and avoid the need for more invasive treatments.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
KOKO device (intrauterine vacuum drain)
What this could lead to
If successful, this device could provide a quick, non-surgical way to stop heavy bleeding after childbirth, potentially reducing the need for more invasive procedures.
What could go wrong
This is an early-stage trial with only 72 participants, so results may not apply to all cases. The device may not control bleeding in every patient, and there is a risk of device-related side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

73 people

The number who actually took part.

Started

Aug 2024

Finished

Jul 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Postpartum Hemorrhage

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hemorrhage, postpartum Immediate postpartum hemorrhage Postpartum hemorrhage

Contacts and locations

Locations

  • Baylor College of Medicine

    Houston, Texas, 77030, United States

  • Christiana Care

    Newark, Delaware, 19718, United States

  • Duke University

    Durham, North Carolina, 27705, United States

  • Indiana University School of Medicine, Dept. of OBGYN

    Indianapolis, Indiana, 46202, United States

  • LSU Heath Sciences Center - Shreveport

    Shreveport, Louisiana, 71103, United States

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • MetroHealth

    Cleveland, Ohio, 44109, United States

  • New York-Presbyterian Hospital (NYPH)/Columbia University Irving Medical Center (CUIMC)

    New York, New York, 10032, United States

  • New York-Presbyterian Medical Group Queens

    Flushing, New York, 11355, United States

  • Sunrise Hospital and Medical Center

    Las Vegas, Nevada, 89109, United States

  • The Cleveland Clinic

    Cleveland, Ohio, 44111, United States

  • The Ohio State University

    Columbus, Ohio, 43210, United States

  • UT Health Houston

    Houston, Texas, 77030, United States

  • University of Alabama

    Birmingham, Alabama, 35233, United States

  • University of Kentucky

    Lexington, Kentucky, 40536, United States

  • University of Miami

    Miami, Florida, 33136, United States

  • University of Utah

    Salt Lake City, Utah, 84132, United States

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