New vacuum device aims to stop postpartum bleeding without surgery

NCT ID NCT06452355

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

First seen Jun 27, 2026 · Last updated Jul 02, 2026 · Updated 1 time

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.

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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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