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

NCT05913609 | Recruiting DMC FDA Device

• 1 other identifier: CLT-005
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Shoulder Dystocia

Outcome Measures

Primary Outcomes (3)

• Number of successful neonate deliveries with the Yaari Extractor device

  First Primary Effectiveness Endpoint

  immediately after the intervention

• Time interval (minutes) from the diagnosis of the shoulder dystocia until the neonate's delivery

  Second Primary Effectiveness Endpoint

  immediately after the intervention

• Maternal and neonatal adverse events

  Primary Safety Endpoint

  through study completion, an average of 5 days

Secondary Outcomes (1)

• Ease of Use 5 point Likert scale User Questionnaire

  immediately after the intervention

Study Arms (2)

Yaari Extractor group

EXPERIMENTAL

Prospective experimental arm

Device: Yaari Extractor

Control group

NO INTERVENTION

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

Interventions

Yaari Extractor DEVICE

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.

Yaari Extractor group

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject 18 years of age or older at time of consent.
• Subject planning on vaginal birth.
• Singleton pregnancy in vertex presentation.
• Full-term pregnancy having completed 37 weeks or more gestational weeks.
• Able and willing to provide written informed consent prior to enrollment.
• In the opinion of the Investigator, the subject has sufficient mental capacity to understand the informed consent form (ICF).
• 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."

You may not qualify if:

• Patients who have undergone attempted delivery using ancillary standard of care maneuvers, to include first-line maneuvers (McRoberts ± suprapubic pressure with downward traction on the fetal head), prior to use of the Yaari Extractor. (NOTE: Hyperflexion of the hips or legs is allowed prior to and during use of the Yaari Extractor.)
• Cesarean section is planned for the patient.
• Obstetric contraindications to vaginal birth.
• Subject carrying fetus with known significant chromosomal or structural anomalies.
• Clinically estimated fetal weight ≥5kg in non-diabetic subjects.
• Clinically estimated fetal weight ≥4.5kg in subjects with diabetes.
• 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.
• Bleeding disorders, such as thrombocytopenia, von Willebrand's disease, bleeding disorder currently using anticoagulation medication, etc.
• Any maternal disease or disorder that precludes the subject from pushing effectively.
• If the maternal cervix is not fully dilated.
• If the fetal head is not completely out of the birth canal.
• In the presence of a non-reducible nuchal cord.

Sponsors & Collaborators

• FetalEase Ltd.: lead

Study Sites (4)

University of Miami - Jackson Memorial

Miami, Florida, 33136, United States

RECRUITING

Rosemark WomenCare Specialist

Idaho Falls, Idaho, 83404, United States

RECRUITING

Unified Women's Clinical Research

Winston-Salem, North Carolina, 27103, United States

RECRUITING

Inova Fairfax Medical Campus

Falls Church, Virginia, 22042, United States

RECRUITING

MeSH Terms

Conditions

Shoulder Dystocia

Condition Hierarchy (Ancestors)

Dystocia; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Central Study Contacts

Ahava Stein

CONTACT

+972522346927; ahava@asteinrac.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2023
• First Posted: June 22, 2023
• Study Start: November 15, 2023
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)