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

Postpartum Hemorrhage Clinical Trial

— SERENE  

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")

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06452355
• Other study ID #: KOKO-PPH-001 (PSD-10212)
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 30, 2024
• Est. completion date: July 30, 2025

Study information

• Verified date: June 2024
• Source: KOKO Medical Inc.
• Contact: Cathy Unruh
• Phone: 610-215-2011
• Email: cathyu[@]kokomed.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This IDE study is designed to evaluate the effectiveness and safety of the KOKO™ device to treat primary abnormal postpartum uterine bleeding or hemorrhage. The study is literature controlled.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 52
• Est. completion date: July 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hemorrhage
• Hemorrhage, Postpartum
• Immediate Postpartum Hemorrhage
• Postpartum Hemorrhage
• Uterine Hemorrhage

Intervention

Device:
• KOKO Device
The intrauterine rolling drain is extended into the uterus, where low pressure vacuum is applied to the uterus through the fabric intrauterine rolling drain. The KOKO™ device utilizes this vacuum to remove excess blood and compress the uterus reducing further blood loss.

Locations

Country	Name	City	State
United States	Cleveland Clinic (Fairview)	Cleveland	Ohio
United States	MetroHealth	Cleveland	Ohio
United States	The Ohio State University	Columbus	Ohio
United States	Ochsner Baptist	New Orleans	Louisiana
United States	New York-Presbyterian Hospital (NYPH)/Columbia University Irving Medical Center (CUIMC)	New York	New York
United States	Christiana Care	Newark	Delaware
United States	University of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
KOKO Medical Inc.

Country where clinical trial is conducted

United States, 

References & Publications (9)

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Time to control abnormal postpartum uterine bleeding or hemorrhage	Time from start of treatment to control of bleeding per protocol	24 Hrs
Secondary	Rate of non-surgical or surgical procedures after KOKO use	Rate of non-surgical or surgical procedures required to control abnormal postpartum uterine bleeding or hemorrhage after KOKO use	24 Hrs
Secondary	Transfusion rate and units	Rate of blood product transfusion required after KOKO use, and number of transfusions units administered	24 Hrs through discharge
Secondary	KOKO Device Usability	Clinician reported assessment of KOKO device usability	24 Hrs