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

NARecruitingINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

November 15, 2023

Primary Completion Date

November 30, 2025

Study Completion Date

April 30, 2026

Conditions
Shoulder Dystocia
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.

Trial Locations (3)

22042

RECRUITING

Inova Fairfax Medical Campus, Falls Church

27103

RECRUITING

Unified Women's Clinical Research, Winston-Salem

33136

RECRUITING

University of Miami - Jackson Memorial, Miami

All Listed Sponsors
lead

FetalEase Ltd.

INDUSTRY