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A Phase 3, Multicenter, Prospective, Randomized, Open-label Study for Intraoperative Ureter(s) Visualization When Using ASP5354 With Near-infrared Fluorescence (NIR-F) Imaging in Adult Participants Undergoing Minimally Invasive and Open Abdominopelvic Surgeries

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A Phase 3, Multicenter, Prospective, Randomized, Open-label Study for Intraoperative Ureter(s) Visualization When Using ASP5354 With Near-infrared Fluorescence (NIR-F) Imaging in Adult Participants Undergoing Minimally Invasive and Open Abdominopelvic Surgeries

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 11 Dec 2024

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At a glance

  • Drugs Pudexacianinium (Primary)
  • Indications Intraoperative complications
  • Focus Diagnostic use; Registrational
  • Sponsors Astellas Pharma Global Development

    • Most Recent Events

    • 22 Oct 2024 Planned End Date changed from 31 Mar 2025 to 31 Dec 2025.
    • 22 Oct 2024 Planned primary completion date changed from 31 Mar 2025 to 31 Dec 2025.
    • 22 Jul 2024 Planned End Date changed from 31 Jul 2024 to 31 Mar 2025.

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