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

Study Overview
=================
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.

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

Conditions
-----------------
Shoulder Dystocia

Intervention / Treatment
-----------------
* Device: Yaari Extractor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Exclusion Criteria: Patients who have undergone ancillary standard of care maneuvers, to include first-line maneuvers (McRoberts/suprapubic pressure), prior to 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Yaari Extractor group<br>Prospective experimental arm | Device: Yaari Extractor<br>* 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.<br>|
| No Intervention: Control group<br>Historical control arm - retrospective review of medical records at the same study sites | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ease of Use 5 point Likert scale User Questionnaire | Secondary Effectiveness Endpoint | immediately after the intervention |