KOKO Device for Postpartum Hemorrhage

(SERENE Trial)

Recruiting at 9 trial locations

Overseen By Gabby Herrmann

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: KOKO Medical Inc.

Must be taking: Uterotonics

Disqualifiers: Uterine anomaly, Placental abnormality, Coagulopathy, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that uterotonics (medications to contract the uterus) can continue to be used alongside the KOKO device.

What data supports the effectiveness of the KOKO Device treatment for postpartum hemorrhage?

The research mentions a novel device designed to facilitate uterine compression, which is a method used to treat postpartum hemorrhage by helping the uterus contract and stop bleeding. This suggests that similar devices have been evaluated for safety and effectiveness in managing postpartum hemorrhage. ^{1 2 3 4 5}

What safety data exists for the KOKO Device for Postpartum Hemorrhage?

There is no specific safety data available for the KOKO Device for Postpartum Hemorrhage in the provided research articles. ^{6 7 8 9 10}

How is the KOKO Device treatment for postpartum hemorrhage different from other treatments?

The KOKO Device is unique because it likely offers a less invasive method to control postpartum hemorrhage, similar to the PPH Butterfly device, which replicates uterine compression without the need for manual insertion, making it more comfortable for the patient. ^{1 2 11 12 13}

Research Team

Dena Goffman, MD

Principal Investigator

Columbia University

Eligibility Criteria

This trial is for individuals who have recently given birth and are experiencing abnormal uterine bleeding or hemorrhage that started soon after delivery. Specific eligibility details are not provided, but typically participants must meet certain health conditions to join.

Inclusion Criteria

I am a woman aged 18 or older.

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

I understand the study and agree to participate.

Exclusion Criteria

My cervix was less than 2.5 cm dilated before using KOKO for my cesarean birth.

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

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

The KOKO device is administered to participants to control and reduce abnormal postpartum uterine bleeding or hemorrhage

24 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including documentation of adverse events and efficacy measures

6 weeks

Treatment Details

Interventions

• KOKO Device (Procedure)

Trial Overview The study is focused on assessing the KOKO Device, which is designed to help control and reduce excessive uterine bleeding or hemorrhage in people who have just given birth.

Participant Groups

Group I: Intervention Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

KOKO Medical Inc.

Lead Sponsor

Trials

1

Recruited

50+

Findings from Research

Postpartum hemorrhage (PPH) is a major cause of maternal mortality, accounting for about 25% of maternal deaths worldwide, highlighting the urgent need for effective interventions.

Uterotonic drugs, along with emerging technologies like anti-shock garments and umbilical vein injection of oxytocin, show promise in reducing PPH-related deaths, but further research and implementation into clinical practice are necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postpartum hemorrhage in developing countries: is the public health community using the right tools? Tsu, VD., Langer, A., Aldrich, T.[2016]

The PPH Butterfly is a new, less invasive medical device designed to replicate bimanual compression (BMC) for managing postpartum hemorrhage (PPH), which is a major cause of maternal complications.

Developed through collaboration with clinicians and consumers, the device is easy to use, low-cost, and has shown promising performance in tests, paving the way for future human trials to assess its effectiveness in PPH management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PPH Butterfly: a novel device to treat postpartum haemorrhage through uterine compression. Cunningham, C., Watt, P., Aflaifel, N., et al.[2021]

The Koohi Goth Vacuum Delivery System (KGVDS) was successfully used in 137 women during complicated deliveries, with an 81% success rate in expelling the fetal head, indicating its efficacy in low-resource settings.

The device demonstrated a high safety profile, with no serious maternal or neonatal injuries reported, and received a positive ease of use rating of 8 out of 10 from healthcare providers, suggesting it is user-friendly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective cohort study of a new vacuum delivery device to assist with complicated labour in low-resource settings. Khan, M., Hashmani, FN., Ahmed, S., et al.[2015]

In a study involving 57 women with postpartum hemorrhage (PPH), the new uterine compression device significantly reduced additional blood loss, with only one participant experiencing over 1000mls of blood loss after its use, indicating its efficacy in managing PPH.

The device was well-accepted by both clinicians and patients, with 85% of clinicians finding it helpful in managing bleeding and all responding women expressing a desire for its use in future births, while no serious adverse events were reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A mixed method, phase 2 clinical evaluation of a novel device to treat postpartum haemorrhage. Weeks, AD., Cunningham, C., Taylor, W., et al.[2023]

Postpartum hemorrhage is a significant global health issue, causing over 125,000 deaths annually, and traditional treatments often involve complex surgical interventions after oxytocic medications fail.

The B-Lynch technique, which involves placing compression sutures in the uterus, offers a simpler first surgical option to control bleeding when standard treatments are ineffective, potentially reducing the need for more invasive procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Uterine compression sutures: surgical management of postpartum hemorrhage. Hayman, RG., Arulkumaran, S., Steer, PJ.[2022]

The FDA's 510(k) pathway for clearing new medical devices has raised safety concerns, prompting discussions on how to better regulate and communicate risks associated with these devices.

To ensure ethical use of 510(k)-cleared devices, it is recommended to exercise caution until more data is available, improve knowledge for informed consent among physicians and patients, and distribute devices based on individual risk assessments while maintaining equitable access.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How Should Clinicians and Organizations Assess Risks and Benefits of First-in-Human Implantation of Investigational Devices? Brown, BL., Kesselheim, AS.[2021]

Adverse medical device events occur at a rate of approximately 8.4 events per 100 hospitalizations, highlighting a significant area of concern for patient safety that is less studied compared to medication-related events.

There is a critical need for further research into the frequency, causes, and outcomes of medical device-related events to develop effective safety strategies, particularly in the context of the German healthcare system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Methodical reflections on epidemiological methods to measure adverse medical device events]. Lessing, C.[2016]

A review of 53 incident reports related to mechanical heart valves revealed serious issues, including 17 cases of leaflet breakage and 12 cases of leaflet dysfunction, often leading to severe outcomes like re-surgery or death.

Despite these incidents, the overall reporting rate suggests that mechanical heart valves are generally safe, indicating the need for improved incident reporting to better identify and address potential failures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Incidents of malfunction of mechanical heart valves as reported to the German Medical Devices Vigilance System]. von Mallek, D., Heinz, BC., Löffler, BG., et al.[2008]

The 'Medical Device Guidebook' is a web-based resource designed to enhance the safe use of medical devices by providing comprehensive information, including user manuals, safety points, and operational procedures for specific models.

By identifying known risks and hazards associated with medical devices, the Guidebook aims to improve user training and reduce the likelihood of equipment misuse, which is a common cause of patient injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medical Device Guidebook: A browser information resource for medical device users. Clarkson, DM.[2018]

Sharp injuries in healthcare settings pose a serious risk for transmitting blood-borne pathogens, but using medical devices with active and passive safety features can significantly reduce this risk.

The paper discusses essential criteria for evaluating safe medical devices, highlights examples of safety equipment, and addresses barriers to their adoption, emphasizing the importance of a user-based system approach for selecting and implementing these safety devices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Safe equipment to prevent injuries in medical staff]. Gańczak, M.[2008]

The B-Lynch surgical technique, which involves placing a brace-like suture over the uterus, was successfully used to control postpartum hemorrhage in seven cases, demonstrating its efficacy in achieving hemostasis.

In four of the seven cases, the B-Lynch technique was the first treatment option, while in three cases it was used after other methods like artery ligation, highlighting its versatility in managing severe bleeding.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The B-Lynch technique for postpartum haemorrhage: an option for every gynaecologist. Holtsema, H., Nijland, R., Huisman, A., et al.[2004]

The three brace suture technique by Esike is a novel and effective method for controlling life-threatening postpartum hemorrhage caused by uterine atony, successfully used in two women while preserving their uterus.

This technique is simple, less invasive, and easy to learn, making it a promising option for wider use in managing postpartum hemorrhage and improving maternal outcomes, especially in developing countries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Esike's three-brace suture technique for controlling life-threatening postpartum hemorrhage - A report of two cases. Uzoma Esike, CO.[2023]

The new uterine compression suture technique described is a safe and effective method for treating postpartum hemorrhage (PPH) caused by uterine atony, minimizing trauma to the uterus by avoiding incisions and suturing the walls together.

This technique has the potential to be particularly beneficial for managing severe PPH following vaginal deliveries, addressing a significant cause of maternal mortality and morbidity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new uterine compression suture for postpartum haemorrhage with atony. Zheng, J., Xiong, X., Ma, Q., et al.[2011]

References

1. United States pubmed.ncbi.nlm.nih.gov

Postpartum hemorrhage in developing countries: is the public health community using the right tools? [2016]

2. England pubmed.ncbi.nlm.nih.gov

PPH Butterfly: a novel device to treat postpartum haemorrhage through uterine compression. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Prospective cohort study of a new vacuum delivery device to assist with complicated labour in low-resource settings. [2015]

4. Ireland pubmed.ncbi.nlm.nih.gov

A mixed method, phase 2 clinical evaluation of a novel device to treat postpartum haemorrhage. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Uterine compression sutures: surgical management of postpartum hemorrhage. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

How Should Clinicians and Organizations Assess Risks and Benefits of First-in-Human Implantation of Investigational Devices? [2021]

7. Germany pubmed.ncbi.nlm.nih.gov

[Methodical reflections on epidemiological methods to measure adverse medical device events]. [2016]

8. Germany pubmed.ncbi.nlm.nih.gov

[Incidents of malfunction of mechanical heart valves as reported to the German Medical Devices Vigilance System]. [2008]

9. England pubmed.ncbi.nlm.nih.gov

Medical Device Guidebook: A browser information resource for medical device users. [2018]

10. Poland pubmed.ncbi.nlm.nih.gov

[Safe equipment to prevent injuries in medical staff]. [2008]

11. Ireland pubmed.ncbi.nlm.nih.gov

The B-Lynch technique for postpartum haemorrhage: an option for every gynaecologist. [2004]

12. India pubmed.ncbi.nlm.nih.gov

Esike's three-brace suture technique for controlling life-threatening postpartum hemorrhage - A report of two cases. [2023]

13. England pubmed.ncbi.nlm.nih.gov

A new uterine compression suture for postpartum haemorrhage with atony. [2011]