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Registry of Avance® Nerve Graft's Utilization and Recovery Outcomes Post Peripheral Nerve Reconstruction

Study acronym: RANGER®
StatusActive, Not Recruiting
PhaseNot specified
Started
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Record History

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  1. Notable Primary and study completion dates: Dec 2025 to Nov 2028
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 5000 to confirmed 3126
    • Site details revised at 49 of 49 sites
    v14
  2. Minor Re-verified, no change to tracked fieldsv13
  3. Minor Study sites: 47 to 49v12
  4. Minor Study sites: 45 to 47v11
  5. Minor Study sites: 41 to 45v10
Show 8 earlier versionsHide 8 earlier versions
  1. Minor Study sites: 39 to 41
    • Eligibility criteria expanded, about 197 words
    v9
  2. Minor Re-verified, no change to tracked fieldsv8
  3. Minor Study sites: 38 to 39v7
  4. Minor Study sites: 35 to 38v6
  5. Notable Enrollment target: 500 to 5000v5 Show 10 more changesShow less
    • Primary completion date: Dec 2018 to Dec 2025
    • Primary endpoints: 1 to 6
    • Study sites: 12 to 35
    • Study completion date: Dec 2020 to Dec 2025
    • Interventions: Processed Human Nerve Tissue Scaffold (Other), Standard Treatment, Autogenous Nerve Graft, Direct Suture, etc. (Other) to Autogenous Nerve Graft (Other), Autologous Breast Reconstruction with Neurotization (Procedure), Autologous Breast Reconstruction without…
    • Eligibility criteria expanded, about 263 words
    • Secondary endpoints: 2 to 3
    • Study description expanded, about 92 words
    • Study arms: 2 to 4
    • Study title shortened, about 3 words
  6. Minor Study completion date: Dec 2020v4
  7. Notable Primary completion date: Dec 2016 to Dec 2018
    • Study sites: 3 to 12
    v3
  8. Minor Re-verified, no change to tracked fieldsv2
  1. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 study is a registry of general use of Avance Nerve Graft and is intended to evaluate the uses, response rates, and safety of Avance Nerve Graft in the real-life clinical setting. Optional addendums 1 and 2 included in the protocol are intended to establish comparative groups and focused subgroups within the registry.
Trial Details
NCT Number NCT01526681
Lead Sponsor Axogen Corporation
Conditions
(from sponsor)
Peripheral Nerve Injuries
Related terms Peripheral Nerve Injuries
Enrollment 3,126 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov