Safety and Effectiveness of the Yaari Extractor for Management of Shoulder Dystocia
Condition(s) studied
Investigational drug(s) / intervention(s)
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.
Study 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.
Eligibility
Primary outcome measure(s)
- Number of successful neonate deliveries with the Yaari Extractor device — immediately after the intervention
First Primary Effectiveness Endpoint - Time interval (minutes) from the diagnosis of the shoulder dystocia until the neonate's delivery — immediately after the intervention
Second Primary Effectiveness Endpoint - Maternal and neonatal adverse events — through study completion, an average of 5 days
Primary Safety Endpoint
Trial sites (4)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Miami - Jackson Memorial | Miami | Florida | Recruiting |
| Rosemark WomenCare Specialist | Idaho Falls | Idaho | Recruiting |
| Unified Women's Clinical Research | Winston-Salem | North Carolina | Recruiting |
| Inova Fairfax Medical Campus | Falls Church | Virginia | Recruiting |
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05913609 on ClinicalTrials.gov ↗ ← All trials in the USA