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Safety and Effectiveness of the Yaari Extractor for Management of Shoulder Dystocia
Sponsor: FetalEase Ltd.
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
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2023-11-15
Completion Date
2027-04
Last Updated
2025-11-25
Healthy Volunteers
Yes
Conditions
Interventions
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 (4)
University of Miami - Jackson Memorial
Miami, Florida, United States
Rosemark WomenCare Specialist
Idaho Falls, Idaho, United States
Unified Women's Clinical Research
Winston-Salem, North Carolina, United States
Inova Fairfax Medical Campus
Falls Church, Virginia, United States