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APrevent-VOIS-Implant-002 - a Two-Part, Open-Label, Non-Randomized Multicenter Study

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated February 6, 2025 (before its estimated September 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Primary completion date: Mar 2024 to Sep 2025
    • Study sites: 4 to 7
    • Study completion date: Dec 2024 to Sep 2026
    v3
  2. Primary completion date: Jun 2022 to Mar 2024
    • Study completion date: Dec 2023 to Dec 2024
    v2
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is a prospective, 2-part, multi-center, open-label, non-randomized clinical trial to assess safety and effectiveness of APrevent® VOIS Implants for the treatment of patients with Unilateral Vocal Fold Paralysis (UVFP). In total 30 evaluable patients are planned to be enrolled.
Trial Details
NCT Number NCT05119842
Lead Sponsor APrevent Biotech GmbH
Conditions
(from sponsor)		 Paralysis, Unilateral, Vocal Cord
Related terms Vocal Cord Paralysis
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov