RECRUITING

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

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Conditions

Postpartum HemorrhageImmediate Postpartum HemorrhageHemorrhage, Postpartum

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-08-29
Study Completion:2026-08-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06452355

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adult Female, 18 years of age or older at time of consent.
  2. * Subject is able to understand and provide informed consent to participate in the study.
  3. * 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.
  4. * 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.
  5. * 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.
  1. * EBL \>1500ml, to be determined when investigator is ready to have the KOKO packaging opened.
  2. * Delivery at a gestational age \< 34 weeks or, if multiples, uterus is judged \<34 weeks size.
  3. * For cesarean births: Cervix \< 2.5 cm dilated before use of KOKO.
  4. * Abnormal postpartum uterine bleeding or hemorrhage that the investigator determines to require more aggressive treatment, including any of the following:
  5. 1. hysterectomy;
  6. 2. B-lynch suture;
  7. 3. uterine artery embolization or ligation;
  8. 4. hypogastric ligation.
  9. * Known uterine anomaly.
  10. * Ongoing intrauterine pregnancy.
  11. * Placental abnormality including any of the following:
  12. 1. known placenta accreta;
  13. 2. retained placenta with known risk factors for placenta accreta (e.g., history of prior uterine surgery, including prior cesarean and placenta previa);
  14. 3. retained placenta without easy manual removal.
  15. * Known uterine rupture.
  16. * Unresolved uterine inversion.
  17. * 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.
  18. * Current cervical cancer.
  19. * Current purulent infection of vagina, cervix, uterus.
  20. * Diagnosis of coagulopathy.

Contacts and Locations

Study Contact

Jason Keiser
CONTACT
610-215-2010
jason@kokomed.com
Gabrielle Herrmann
CONTACT
610-215-2010
gabby@kokomed.com

Principal Investigator

Dena Goffman, MD
PRINCIPAL_INVESTIGATOR
Columbia University

Study Locations (Sites)

University of Alabama
Birmingham, Alabama, 35233
United States
Christiana Care
Newark, Delaware, 19718
United States
Indiana University School of Medicine, Dept. of OBGYN
Indianapolis, Indiana, 46202
United States
Ochsner Baptist
New Orleans, Louisiana, 70115
United States
New York-Presbyterian Hospital (NYPH)/Columbia University Irving Medical Center (CUIMC)
New York, New York, 10032
United States
MetroHealth
Cleveland, Ohio, 44109
United States
The Cleveland Clinic
Cleveland, Ohio, 44111
United States
The Ohio State University
Columbus, Ohio, 43210
United States
University of Utah
Salt Lake City, Utah, 84132
United States

Collaborators and Investigators

Sponsor: KOKO Medical Inc.

  • Dena Goffman, MD, PRINCIPAL_INVESTIGATOR, Columbia University

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 Registration Dates

Study Start Date2024-08-29
Study Completion Date2026-08-30

Study Record Updates

Study Start Date2024-08-29
Study Completion Date2026-08-30

Terms related to this study

Additional Relevant MeSH Terms

  • Postpartum Hemorrhage
  • Immediate Postpartum Hemorrhage
  • Hemorrhage, Postpartum