Yaari Extractor for Shoulder Dystocia

Recruiting at 3 trial locations

Overseen By Ahava Stein

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: FetalEase Ltd.

Must not be taking: Anticoagulants

Disqualifiers: Planned cesarean, Fetal anomalies, Diabetes, Bleeding disorders, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: immediate

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and effectiveness of the Yaari Extractor, a tool used during childbirth to assist in delivering babies when their shoulders get stuck, a condition known as shoulder dystocia. The trial will compare outcomes with historical data from similar cases. It is open to pregnant women planning a vaginal birth, who have reached full term, and are experiencing shoulder dystocia during labor. Participants should not have undergone certain maneuvers to assist birth before using the Yaari Extractor. As an unphased trial, participants can contribute to important research that may improve childbirth outcomes.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are using anticoagulation medication for a bleeding disorder, you may not be eligible to participate.

What prior data suggests that the Yaari Extractor device is safe for managing shoulder dystocia?

Research shows that the Yaari Extractor is designed to assist with births complicated by shoulder dystocia, a condition where a baby's shoulder becomes stuck during delivery. The device guides the baby's shoulder to make the delivery safer.

Specific studies on the Yaari Extractor's safety for humans are not yet available, and the trial phase is labeled as "Not Applicable." This label might indicate an early or specialized study, suggesting limited direct safety data for humans at this stage.

However, the device aims to reduce the risk of injury during childbirth. Devices like this typically undergo safety testing before trial use, implying that the Yaari Extractor is intended to be safe. More studies could provide further confirmation. Always consult a healthcare professional if there are concerns before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Yaari Extractor is unique because it offers a new approach to managing shoulder dystocia, a complication during childbirth. Unlike traditional methods, which often rely on manual maneuvers to free the baby’s shoulder, the Yaari Extractor introduces a mechanical aid designed to assist in the delivery process more efficiently. Researchers are excited about this treatment because it has the potential to reduce delivery time and improve outcomes for both mothers and babies, providing a safer and more controlled alternative to current practices.

What evidence suggests that the Yaari Extractor is effective for managing shoulder dystocia?

Research shows that the Yaari Extractor, which participants in this trial may receive, is designed to assist with shoulder dystocia, a condition where a baby's shoulder becomes stuck during birth. Studies have found that this device uses a special band to safely and quickly guide the baby's shoulder out. The goal is to lower the risk of birth injuries by freeing the shoulder before any harm occurs. Early evidence suggests it effectively aids in delivering babies when shoulder dystocia occurs. Devices like this can make childbirth safer and help prevent problems linked to this condition. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are at least 37 weeks pregnant, expecting a single baby in head-down position, and planning a vaginal birth. It's specifically for those experiencing shoulder dystocia during delivery—a condition where the baby's shoulder gets stuck after the head is born. Participants must understand and agree to the study.

Inclusion Criteria

You are planning to give birth vaginally.

I understand the consent form for this study.

You are pregnant with only one baby positioned head-down.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive the Yaari Extractor intervention for management of shoulder dystocia

immediate

1 visit (in-person)

Follow-up

Participants are monitored for maternal and neonatal adverse events

5 days

What Are the Treatments Tested in This Trial?

Interventions

• Yaari Extractor

Trial Overview The Yaari Extractor—a device designed to help safely deliver babies when shoulder dystocia occurs—is being tested by OB/GYNs across multiple centers. The study compares its safety and effectiveness against past methods used for this complication.

How Is the Trial Designed?

Group I: Yaari Extractor group Experimental Treatment 1 Intervention

Prospective experimental arm

Group II: Control group Active Control 1 Intervention

Historical control arm - retrospective review of medical records at the same study sites

Yaari Extractor is already approved in United States for the following indications:

Approved in United States as Yaari Extractor for:

• Management of Shoulder Dystocia

Who Is Running the Clinical Trial?

FetalEase Ltd.

Lead Sponsor

Trials

1

Recruited

80+

Published Research Related to This Trial

Shoulder dystocia is a rare but serious complication during childbirth, occurring in about 1 in 10,000 deliveries, making it difficult for individual obstetricians to gain sufficient experience for effective management.

The author has developed a new obstetric instrument called the 'shoulder born' that may help manage shoulder dystocia by creating a channel to facilitate the delivery of the anterior shoulder, potentially reducing trauma during the process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new instrument for the management of shoulder dystocia. Chavis, WM.[2019]

The use of a vacuum extractor during delivery is associated with a significantly higher risk of shoulder dystocia (SD) compared to spontaneous vaginal delivery, with odds ratios of 2.87 and 2.98 in different models.

There is no significant difference in the occurrence of shoulder dystocia between vacuum and forceps deliveries, indicating that while vacuum delivery increases risk compared to spontaneous delivery, it does not pose a greater risk than forceps.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does vacuum delivery carry a higher risk of shoulder dystocia? Review and meta-analysis of the literature. Dall'Asta, A., Ghi, T., Pedrazzi, G., et al.[2017]

The new endoscopic extractor for foreign body removal has demonstrated successful use, allowing for 360-degree rotation to grasp objects from any angle.

This device utilizes a band-like snare with tiny studs for effective capture and extraction, ensuring a quick and safe procedure for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopic removal of foreign bodies using a newly developed extractor. Hennig, AE., Seuberth, K.[2004]

The new retractor-shaped and spatula-shaped wire devices developed for total endoscopic thyroidectomy were used safely in 18 patients, with no cases of hemorrhage or conversion to open surgery, indicating their effectiveness in maintaining surgical safety.

These devices allowed for successful procedures on larger thyroid lesions and patients with previous thyroid surgeries or conditions like Graves' disease and chronic thyroiditis, demonstrating their versatility in complex cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Total endoscopic thyroidectomy via a unilateral axillo-breast approach with two spatula-shaped wires each attached to the end of an endoscopic aspirator and a retractor-shaped wire. Luangchana, V.[2018]

In a study of 107 medical records, shoulder dystocia was frequently associated with high fetal weights, with 75% of cases involving babies weighing over 4,000 grams, indicating that macrosomia is a significant risk factor for fetal injuries during delivery.

Almost one-third of the cases resulted in permanent hypoxic or traumatic cerebral damage, highlighting the serious consequences of shoulder dystocia, especially when instrumental delivery methods like forceps or vacuum extraction were used.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Common intrapartum denominators of shoulder dystocia related birth injuries. Iffy, L., Varadi, V., Jakobovits, A.[2016]

A new device made from a plastic syringe and two needles provides a safe and effective way to approximate severed nerves or tendons without tension, which is crucial for proper healing.

This practical tool simplifies the process of nerve or tendon repair, potentially improving outcomes in surgical procedures involving these structures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nerve and tendon approximator. Bayramiçli, M., Gürünlüoğlu, R., Yilmaz, B., et al.[2009]

The proposed veinextractor is designed specifically for the dissection and extraction of varicose and thrombosed veins in the lower limbs, featuring a unique head shape that minimizes trauma during the procedure.

Using this veinextractor has resulted in reduced tissue damage and improved cosmetic outcomes for patients undergoing vein removal surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Vein extractor]. Komarov, IA., Romanovskiĭ, AV.[2006]

The Yaari Extractor is a new single-use device designed to assist in vaginal delivery during shoulder dystocia, successfully used in three cases without the need for additional obstetric maneuvers.

In all instances, the device resolved the shoulder dystocia effectively, with no reported injuries to either the mother or the fetus, indicating its safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Extractor for the Management of Shoulder Dystocia. Gherman, RB., Patel, R.[2023]

Prophylactic manoeuvres, like the McRobert's manoeuvre, may reduce the incidence of shoulder dystocia during childbirth, as indicated by one study showing fewer cases in the prophylactic group compared to the control group (RR 0.44).

However, the use of these manoeuvres was associated with a higher rate of caesarean sections, suggesting that while they may help prevent shoulder dystocia, they could also lead to more surgical interventions during delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intrapartum interventions for preventing shoulder dystocia. Athukorala, C., Middleton, P., Crowther, CA.[2022]

The development of a new combined extractor allows for both central and lateral grasping techniques, enhancing the effectiveness of endovascular procedures.

This extractor is particularly useful for removing foreign bodies, such as catheters, which can improve patient outcomes during complex medical interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potential use of a combined extractor in intravascular procedures. Sochman, J., Peregrin, JH.[2016]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05913609

Safety and Effectiveness of the Yaari Extractor for ... The Yaari Extractor device is a single-use prescription device for neonatal extraction in deliveries that are complicated by shoulder dystocia. The Study Device ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36356249/

An Extractor for the Management of Shoulder Dystocia The Yaari Extractor is intended to wrap around and guide the fetal shoulder to facilitate vaginal delivery in cases of shoulder dystocia.

3. withpower.com withpower.com/trial/phase-dystocia-8-2023-6c009

Yaari Extractor for Shoulder Dystocia This device utilizes a band-like snare with tiny studs for effective capture and extraction, ensuring a quick and safe procedure for patients.

4. trialx.com trialx.com/clinical-trials/listings/281159/safety-and-effectiveness-of-the-yaari-extractor-for-management-of-shoulder-dystocia/

Safety and Effectiveness of the Yaari Extractor for ... Clinical trial for Shoulder Dystocia , Safety and Effectiveness of the Yaari Extractor for Management of Shoulder Dystocia.

5. childbirthinjuries.com childbirthinjuries.com/blog/device-could-prevent-shoulder-dystocia-complications/

New Device Could Prevent Shoulder Dystocia Complications The Yaari Extractor can decrease the risk of shoulder dystocia birth injuries by freeing the baby's shoulders before the baby suffers an injury ...

6. ctv.veeva.com ctv.veeva.com/study/safety-and-effectiveness-of-the-yaari-extractor-for-management-of-shoulder-dystocia

Safety and Effectiveness of the Yaari Extractor for ... Prospective, multi-center, single arm with historical control, to verify the safety and effectiveness of the Yaari Extractor used by board certified or board ...