Clinical Trial: Safety and Effectiveness of the Yaari Extractor for Management of Shoulder Dystocia
Study Status: RECRUITING
Recruit Status: RECRUITING
Study Type: INTERVENTIONAL
Official Title: IDE Clinical Study to Evaluate the Safety and Effectiveness of the Yaari Extractor for Management of Shoulder Dystocia
Brief 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.
Detailed Summary:
Sponsor: FetalEase Ltd.
Current Primary Outcome: First Primary Effectiveness Endpoint
Original Primary Outcome: First Primary Effectiveness Endpoint
Current Secondary Outcome:
Original Secondary Outcome:
Information By: FetalEase Ltd.
Dates:
Date Received: June 08, 2023
Date Started: November 15, 2023
Date Completion: November 15, 2023
Last Updated: November 21, 2023
Last Verified: November 01, 2023