Safety and Effectiveness of the Yaari Extractor for Management of Shoulder Dystocia

Shoulder Dystocia Clinical Trial

Official title:

IDE Clinical Study to Evaluate the Safety and Effectiveness of the Yaari Extractor for Management of Shoulder Dystocia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05913609
• Other study ID #: CLT-005
• Status: Recruiting
• Phase: N/A
• Start date: November 15, 2023
• Est. completion date: April 2026

Study information

• Verified date: May 2024
• Source: FetalEase Ltd.
• Contact: Ahava Stein
• Phone: +972522346927
• Email: ahava[@]asteinrac.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Prospective, multi-center, single arm with historical control, to verify the safety and effectiveness of the Yaari Extractor used by board certified or board eligible U.S. OB/GYN physicians in the management of shoulder dystocia.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: April 2026
• Est. primary completion date: November 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Subject 18 years of age or older at time of consent.

2. Subject planning on vaginal birth.

3. Singleton pregnancy in vertex presentation.

4. Full-term pregnancy having completed 37 weeks or more gestational weeks.

5. Able and willing to provide written informed consent prior to enrollment.

6. In the opinion of the Investigator, the subject has sufficient mental capacity to understand the informed consent form (ICF).

7. Subject with fetus experiencing shoulder dystocia as defined by ACOG Practice Bulletin 178 "Shoulder dystocia is most commonly diagnosed as failure to deliver the fetal shoulder(s) with gentle downward traction on the fetal head, requiring additional maneuvers to effect delivery."

Exclusion Criteria:

1. Patients who have undergone ancillary standard of care maneuvers, to include first-line maneuvers (McRoberts/suprapubic pressure), prior to use of the Yaari Extractor.

2. Cesarean section is planned for the patient.

3. Obstetric contraindications to vaginal birth.

4. Subject carrying fetus with known significant chromosomal or structural anomalies.

5. Clinically estimated fetal weight =5kg in non-diabetic subjects.

6. Clinically estimated fetal weight =4.5kg in subjects with diabetes.

7. Subject has any general health condition or systemic disease that may represent, in the opinion of the Investigator, a potential increased risk associated with device use or pregnancy.

8. Bleeding disorders, such as thrombocytopenia, von Willebrand's disease, bleeding disorder currently using anticoagulation medication, etc.

9. Any maternal disease or disorder that precludes the subject from pushing effectively.

10. If the maternal cervix is not fully dilated.

11. If the fetal head is not completely out of the birth canal.

12. In the presence of a non-reducible nuchal cord.

Related Conditions & MeSH terms

• Dystocia
• Shoulder Dystocia

Intervention

Device:
• Yaari Extractor
The Yaari Extractor device is a single-use prescription device for neonatal extraction in deliveries that are complicated by shoulder dystocia. The Study Device consists of two curved, rigid plastic-coated metal Arms with Handles which are used for control of the device outside the body, and an elastic Engagement Element which conforms to the maternal and neonatal anatomy, and which is used for direct contact with the entrapped neonate within the birth canal.

Locations

Country	Name	City	State
United States	Inova Fairfax Medical Campus	Falls Church	Virginia
United States	Unified Women's Clinical Research	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
FetalEase Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of successful neonate deliveries with the Yaari Extractor device	First Primary Effectiveness Endpoint	immediately after the intervention
Primary	Time interval (minutes) from the diagnosis of the shoulder dystocia until the neonate's delivery	Second Primary Effectiveness Endpoint	immediately after the intervention
Primary	Maternal and neonatal adverse events	Primary Safety Endpoint	through study completion, an average of 5 days
Secondary	Ease of Use 5 point Likert scale User Questionnaire	Secondary Effectiveness Endpoint	immediately after the intervention