IDE Clinical Study to Evaluate the Safety and Effectiveness of the Yaari Extractor for Management of Shoulder Dystocia
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.
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- Yes
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 de…
Interventions
- DeviceYaari 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 MemorialMiami, Florida
- Rosemark WomenCare SpecialistIdaho Falls, Idaho
- Unified Women's Clinical ResearchWinston-Salem, North Carolina
- Inova Fairfax Medical CampusFalls Church, Virginia