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

NCT06452355 | Recruiting DMC FDA Device

• 1 other identifier: KOKO-PPH-001 (PSD-10212)
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 19

Brief 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.

Conditions

Postpartum Hemorrhage; Immediate Postpartum Hemorrhage; Hemorrhage, Postpartum

Outcome Measures

Primary Outcomes (2)

• Efficacy: Rate of Participants With Cessation of Abnormal Postpartum Uterine Bleeding or Hemorrhaging

  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.

  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 Outcomes (4)

• Time to control abnormal postpartum uterine bleeding or hemorrhage

  24 Hrs

• Rate of non-surgical or surgical procedures after KOKO use

  24 Hrs

• Transfusion rate and units

  24 Hrs through discharge

• KOKO Device Usability

  24 Hrs

Study Arms (1)

Intervention

EXPERIMENTAL

The KOKO device will be administered to participants who are diagnosed with abnormal postpartum uterine bleeding or hemorrhage.

Device: KOKO Device

Interventions

KOKO Device 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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Conditions treated occur only in females of childbearing age (i.e., abnormal postpartum uterine bleeding or hemorrhage)
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• hysterectomy;
• B-lynch suture;
• uterine artery embolization or ligation;
• hypogastric ligation.
• Known uterine anomaly.
• Ongoing intrauterine pregnancy.
• Placental abnormality including any of the following:
• known placenta accreta;
• retained placenta with known risk factors for placenta accreta (e.g., history of prior uterine surgery, including prior cesarean and placenta previa);
• retained placenta without easy manual removal.
• Known uterine rupture.

Sponsors & Collaborators

• KOKO Medical Inc.: lead

Study Sites (19)

University of Alabama

Birmingham, Alabama, 35233, United States

RECRUITING

Christiana Care

Newark, Delaware, 19718, United States

RECRUITING

University of Miami

Miami, Florida, 33136, United States

RECRUITING

Indiana University School of Medicine, Dept. of OBGYN

Indianapolis, Indiana, 46202, United States

RECRUITING

University of Kentucky

Lexington, Kentucky, 40536, United States

RECRUITING

Ochsner Baptist

New Orleans, Louisiana, 70115, United States

WITHDRAWN

LSU Heath Sciences Center - Shreveport

Shreveport, Louisiana, 71103, United States

RECRUITING

Sunrise Hospital and Medical Center

Las Vegas, Nevada, 89109, United States

RECRUITING

New York-Presbyterian Medical Group Queens

Flushing, New York, 11355, United States

RECRUITING

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

New York, New York, 10032, United States

RECRUITING

Duke University

Durham, North Carolina, 27705, United States

RECRUITING

MetroHealth

Cleveland, Ohio, 44109, United States

RECRUITING

The Cleveland Clinic

Cleveland, Ohio, 44111, United States

RECRUITING

The Ohio State University

Columbus, Ohio, 43210, United States

RECRUITING

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

Baylor College of Medicine

Houston, Texas, 77030, United States

RECRUITING

UT Health Houston

Houston, Texas, 77030, United States

NOT YET RECRUITING

UT Health San Antonio

San Antonio, Texas, 78229, United States

NOT YET RECRUITING

University of Utah

Salt Lake City, Utah, 84132, United States

RECRUITING

Related Publications (9)

• Naz H, Sarwar I, Fawad A, Nisa AU. Maternal morbidity and mortality due to primary PPH--experience at Ayub Teaching Hospital Abbottabad. J Ayub Med Coll Abbottabad. 2008 Apr-Jun;20(2):59-65.

  PMID: 19385460 BACKGROUND

• Say L, Chou D, Gemmill A, Tuncalp O, Moller AB, Daniels J, Gulmezoglu AM, Temmerman M, Alkema L. Global causes of maternal death: a WHO systematic analysis. Lancet Glob Health. 2014 Jun;2(6):e323-33. doi: 10.1016/S2214-109X(14)70227-X. Epub 2014 May 5.

  PMID: 25103301 BACKGROUND

• Carroli G, Cuesta C, Abalos E, Gulmezoglu AM. Epidemiology of postpartum haemorrhage: a systematic review. Best Pract Res Clin Obstet Gynaecol. 2008 Dec;22(6):999-1012. doi: 10.1016/j.bpobgyn.2008.08.004. Epub 2008 Sep 25.

  PMID: 18819848 BACKGROUND

• McLintock C, James AH. Obstetric hemorrhage. J Thromb Haemost. 2011 Aug;9(8):1441-51. doi: 10.1111/j.1538-7836.2011.04398.x.

  PMID: 21668737 BACKGROUND

• AbouZahr C. Global burden of maternal death and disability. Br Med Bull. 2003;67:1-11. doi: 10.1093/bmb/ldg015.

  PMID: 14711750 BACKGROUND

• Kramer MS, Dahhou M, Vallerand D, Liston R, Joseph KS. Risk factors for postpartum hemorrhage: can we explain the recent temporal increase? J Obstet Gynaecol Can. 2011 Aug;33(8):810-819. doi: 10.1016/S1701-2163(16)34984-2.

  PMID: 21846436 BACKGROUND

• Bateman BT, Berman MF, Riley LE, Leffert LR. The epidemiology of postpartum hemorrhage in a large, nationwide sample of deliveries. Anesth Analg. 2010 May 1;110(5):1368-73. doi: 10.1213/ANE.0b013e3181d74898. Epub 2010 Mar 17.

  PMID: 20237047 BACKGROUND

• D'Alton ME, Rood KM, Smid MC, Simhan HN, Skupski DW, Subramaniam A, Gibson KS, Rosen T, Clark SM, Dudley D, Iqbal SN, Paglia MJ, Duzyj CM, Chien EK, Gibbins KJ, Wine KD, Bentum NAA, Kominiarek MA, Tuuli MG, Goffman D. Intrauterine Vacuum-Induced Hemorrhage-Control Device for Rapid Treatment of Postpartum Hemorrhage. Obstet Gynecol. 2020 Nov;136(5):882-891. doi: 10.1097/AOG.0000000000004138.

  PMID: 32909970 BACKGROUND

• Suarez S, Conde-Agudelo A, Borovac-Pinheiro A, Suarez-Rebling D, Eckardt M, Theron G, Burke TF. Uterine balloon tamponade for the treatment of postpartum hemorrhage: a systematic review and meta-analysis. Am J Obstet Gynecol. 2020 Apr;222(4):293.e1-293.e52. doi: 10.1016/j.ajog.2019.11.1287. Epub 2020 Jan 6.

  PMID: 31917139 BACKGROUND

MeSH Terms

Conditions

Postpartum Hemorrhage

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dena Goffman, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

• Brian Iriye, MD

  Sunrise Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Darra Bigelow

CONTACT

610-215-2010; darra@kokomed.com

Gabrielle Herrmann

CONTACT

610-215-2010; gabby@kokomed.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Phase A is considered a Pilot Study during which 20 subjects were enrolled. Phase B will enroll up to 52 additional subjects.

Study Record Dates

• First Submitted: June 5, 2024
• First Posted: June 11, 2024
• Study Start: August 29, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (19)