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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Shoulder Dystocia
• Intervention / Treatment: Device: Yaari Extractor

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahava Stein; Phone Number: +972522346927; Email: ahava@asteinrac.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Yaari Extractor group; Prospective experimental arm	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.
No Intervention: Control group; 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

Collaborators and Investigators

• Sponsor: FetalEase Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2023
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: June 8, 2023
• First Submitted That Met QC Criteria: June 21, 2023
• First Posted (Actual): June 22, 2023

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 21, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Dystocia; Shoulder Dystocia
• Other Study ID Numbers: CLT-005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes