KOKO Device for Postpartum Hemorrhage

(SERENE Trial)

Recruiting at 18 trial locations

Overseen By Darra Bigelow

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: KOKO Medical Inc.

Must be taking: Uterotonics

Disqualifiers: Uterine anomaly, Placental abnormality, Coagulopathy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 24 hours

72 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the KOKO device to determine if it safely and effectively controls heavy bleeding after childbirth, known as postpartum hemorrhage. The focus is on women who have experienced significant blood loss after giving birth and for whom first-line treatments like medication and massage have not stopped the bleeding. It aims to assist those who have had a vaginal or cesarean birth and are dealing with this issue within 24 hours afterward. As an unphased trial, this study offers participants the opportunity to contribute to important research that could lead to new solutions for postpartum 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 prior data suggests that the KOKO device is safe for postpartum hemorrhage?

Research shows that the KOKO Device is designed to help control and reduce bleeding after childbirth. Although specific safety data for this device is not yet available, insights can be drawn from similar devices. In 2020, the FDA approved a device that gently helps the uterus contract to stop bleeding, suggesting that these types of devices are generally safe.

Additionally, studies on similar devices indicate ease of use, with 98% of researchers finding them simple to operate and 97% recommending them. However, since direct safety data for the KOKO Device is lacking, participants should discuss any potential risks with their healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for postpartum hemorrhage, which typically involve medications like oxytocin or surgical interventions, the KOKO Device offers a mechanical approach to directly manage uterine bleeding. The device’s unique design allows for immediate application to the uterus, potentially providing faster control of hemorrhage. Researchers are excited about the KOKO Device because it could reduce the need for more invasive procedures and medications, making it a potentially safer and more efficient option for new mothers experiencing severe bleeding after childbirth.

What evidence suggests that the KOKO device is effective for postpartum hemorrhage?

Studies have shown that the KOKO™ device, which participants in this trial will receive, effectively controls severe bleeding after childbirth, known as postpartum hemorrhage. It successfully managed bleeding in 93% of women who had a vaginal birth and 84% of those who had a cesarean section. The device uses a vacuum to quickly stop the bleeding, and doctors find it easy to use and effective. Most doctors who used it said they would recommend it because it is simple to use and works well in managing bleeding. These findings suggest the KOKO™ device could be a reliable option for controlling postpartum bleeding. ^{2 3 5 6 7}

Who Is on the Research Team?

Brian Iriye, MD

Principal Investigator

Sunrise Hospital

Dena Goffman, MD

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• KOKO Device

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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 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]

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]

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]

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]

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]

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]

Citations

1. trialx.com trialx.com/clinical-trials/listings/296462/safety-and-effectiveness-of-the-koko-device-to-treat-primary-abnormal-postpartum-uterine-bleeding-or-hemorrhage/

Safety and Effectiveness of the KOKO Device to Treat ... This IDE study is designed to evaluate the effectiveness and safety of the KOKO™ device to treat primary abnormal postpartum uterine bleeding or ...

2. withpower.com withpower.com/trial/phase-postpartum-hemorrhage-5-2024-fcd92

KOKO Device for Postpartum Hemorrhage (SERENE 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 ...

3. cuimc.columbia.edu cuimc.columbia.edu/news/new-device-rapidly-controls-postpartum-hemorrhage

New Device Rapidly Controls Postpartum Hemorrhage Overall, the device succeeded in controlling hemorrhage in 93% of patients who delivered vaginally and 84% who delivered by cesarean. The ...

4. research-studies.allinforhealth.info research-studies.allinforhealth.info/us/en/listing/13326/clinical-trial-designed-to/

Clinical Trial Designed to Assess the Safety and The purpose of this study is to evaluate the safety and effectiveness of the KOKO™ device in the control and reduction of primary abnormal ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7575019/

Intrauterine Vacuum-Induced Hemorrhage-Control Device ... The majority of investigators reported the intrauterine vacuum-induced hemorrhage-control device as easy to use (98%) and would recommend it (97%). CONCLUSION:.

6. ctv.veeva.com ctv.veeva.com/study/safety-and-effectiveness-of-the-koko-device-to-treat-primary-abnormal-postpartum-uterine-bleeding-or

Safety and Effectiveness of the KOKO Device to Treat Primary ... 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 ...

7. trialstoday.org trialstoday.org/trial/NCT06452355

Safety and Effectiveness of the KOKO Device to Treat ... 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 ...