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