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RECRUITING
NCT05913609
NA

Safety and Effectiveness of the Yaari Extractor for Management of Shoulder Dystocia

Sponsor: FetalEase Ltd.

View on ClinicalTrials.gov

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

Interventions

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.

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