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Tolerability and Feasibility Pilot Clinical Study of a Large-Diameter Nerve Cap for Protecting and Preserving Terminated Nerve Ends

Study acronym: REPOSE-XL℠
StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Re-verified, no change to tracked fieldsv9
  2. Minor Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 2 of 2 sites
    v8
  3. Notable Primary and study completion dates: Nov 2024 to Dec 2026v7
  4. Minor Eligibility criteria shortened, about 50 words
    • Secondary endpoints revised (7)
    • Site contacts updated at 2 of 2 sites
    v6
  5. Minor Re-verified, no change to tracked fieldsv5
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  1. Minor Site details revised at 1 of 2 sitesv4
  2. Notable Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
    • Primary and study completion dates: Mar 2024 to Nov 2024
    • Start date changed from estimate of Jul 2021 to Mar 2, 2022
    • Site details revised at 2 of 2 sites
    • Eligibility criteria expanded, about 3 words
  3. Notable Start date: May 2021 to Jul 2021v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 pilot study evaluates the tolerability and feasibility of the Axoguard Large-Diameter Nerve Cap (sizes 5-7 mm) for protecting and preserving terminated nerve endings after limb trauma or amputation when immediate attention to the nerve injuries is not possible.
Trial Details
NCT Number NCT04865679
Lead Sponsor Axogen Corporation
Conditions
(from sponsor)
Symptomatic Neuroma, Amputation, Chronic Nerve Pain
Related terms Nervous System Diseases, Neuralgia, Neuroma, Peripheral Nerve Injuries, Peripheral Nervous System Diseases, Trauma, Nervous System
Enrollment 15 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov