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Study to Evaluate the Safety and Efficacy of AM3101 to Augment Meniscal Healing

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Jan 2026 to Jan 2027v6
  2. Study sites: 1 to 3v5
  3. Primary completion date: Jan 2024 to Jan 2026 Completion date: Jun 2024 to Jun 2027v4 Show 1 more changeShow less
    • Completion date: Jun 2024 to Jun 2027
  4. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Oct 2022 to Apr 26, 2023 · Site details revisedv3 Show 2 more changesShow less
    • Start date changed from estimate of Oct 2022 to Apr 26, 2023
    • Site details revised
  5. Re-verified, no change to tracked fieldsv2
  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The purpose of this clinical trial is to assess the safety and efficacy of AM3101 to facilitate meniscal repair and reduce the incidence of non-healing complications and morbidities associated with a failed meniscal repair. This is a prospective, randomized, controlled, double-blinded, multi-center study.
Trial Details
NCT Number NCT05560477
Lead Sponsor University of Cincinnati
Collaborators: United States Department of Defense
Conditions Meniscus Tear
Enrollment 74 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov