NCT05913609

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: FetalEase Ltd. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Shoulder Dystocia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-11-15
• Primary completion: 2026-11-01
• Completion: 2027-04-01
• First posted: 2023-06-22
• Last updated: 2025-11-25

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study