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

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Site details revised at 1 of 4 sitesv8
  2. Primary completion date: Nov 2025 to Nov 2026
    • Study sites: 3 to 4
    • Study completion date: Apr 2026 to Apr 2027
    • Eligibility criteria expanded, about 30 words
    v7
  3. Site details revised at 1 of 3 sitesv6
  4. Study sites: 2 to 3v5
  5. Site details revised at 1 of 2 sitesv4
Show 2 earlier versionsHide 2 earlier versions
  1. Study sites: 1 to 2v3
  2. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Study sites: 0 to 1
    • Primary completion date: Sep 2025 to Nov 2025
    • Study completion date: Dec 2025 to Apr 2026
    • Start date changed from estimate of Sep 2023 to Nov 15, 2023
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05913609
Lead Sponsor FetalEase Ltd.
Conditions
(from sponsor)		 Shoulder Dystocia
Related terms Shoulder Dystocia
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov