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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
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.
University of Miami - Jackson Memorial
Miami, Florida, United States
RECRUITINGRosemark WomenCare Specialist
Idaho Falls, Idaho, United States
RECRUITINGUnified Women's Clinical Research
Winston-Salem, North Carolina, United States
RECRUITINGNumber of successful neonate deliveries with the Yaari Extractor device
First Primary Effectiveness Endpoint
Time frame: immediately after the intervention
Time interval (minutes) from the diagnosis of the shoulder dystocia until the neonate's delivery
Second Primary Effectiveness Endpoint
Time frame: immediately after the intervention
Maternal and neonatal adverse events
Primary Safety Endpoint
Time frame: through study completion, an average of 5 days
Ease of Use 5 point Likert scale User Questionnaire
Secondary Effectiveness Endpoint
Time frame: immediately after the intervention
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Inova Fairfax Medical Campus
Falls Church, Virginia, United States
RECRUITING