RecruitingNot ApplicableNCT06452355

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

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


Sponsor

KOKO Medical Inc.

Enrollment

72 participants

Start Date

Aug 29, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying KOKO Device for people with hemorrhage, postpartum, immediate postpartum hemorrhage, and other related conditions. The study is currently recruiting participants at 19 locations. People eligible for this study include women aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEKOKO 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.


Locations(19)

University of Alabama

Birmingham, Alabama, United States

Christiana Care

Newark, Delaware, United States

University of Miami

Miami, Florida, United States

Indiana University School of Medicine, Dept. of OBGYN

Indianapolis, Indiana, United States

University of Kentucky

Lexington, Kentucky, United States

Ochsner Baptist

New Orleans, Louisiana, United States

LSU Heath Sciences Center - Shreveport

Shreveport, Louisiana, United States

Sunrise Hospital and Medical Center

Las Vegas, Nevada, United States

New York-Presbyterian Medical Group Queens

Flushing, New York, United States

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

New York, New York, United States

Duke University

Durham, North Carolina, United States

MetroHealth

Cleveland, Ohio, United States

The Cleveland Clinic

Cleveland, Ohio, United States

The Ohio State University

Columbus, Ohio, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Baylor College of Medicine

Houston, Texas, United States

UT Health Houston

Houston, Texas, United States

UT Health San Antonio

San Antonio, Texas, United States

University of Utah

Salt Lake City, Utah, United States

View Full Details on ClinicalTrials.gov

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NCT06452355


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