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Nerve Protection Evaluation: Revision Cubital Tunnel Syndrome Decompression

Study acronym: COVERED
StatusCompleted
PhaseNot applicable
Started
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Record History

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  1. Trial completed Show 5 more changesShow less
    • Primary completion date changed from estimate of Dec 2026 to Aug 17, 2026
    • Enrollment target: estimated 20 to confirmed 19
    • Eligibility criteria expanded, about 37 words
    • Secondary endpoints: details revised at 3 of 8 entries
    • Study description expanded, about 4 words
  2. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 7 of 7 sites
    v5
  3. Study sites: 3 to 7v4
  4. Eligibility criteria shortened, about 25 wordsv3
  5. Study sites: 1 to 3
    • Primary and study completion dates: Jul 2026 to Dec 2026
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This single-cohort, prospective case series is designed to evaluate and characterize the use of Axoguard HA+ Nerve Protector™ to protect the ulnar nerve in a first revision cubital tunnel decompression procedure. Data on the primary cubital tunnel syndrome decompression, first revision decompression utilizing Axoguard HA+ Nerve Protector, participant-reported pain, motor and sensory functional outcomes, quality of life (QoL) outcomes, and recurrence/revision will be collected. This case series will help to establish the ability of Axoguard HA+ Nerve Protector to provide clinical benefits for patients undergoing a first revision cubital tunnel decompression procedure.
Trial Details
NCT Number NCT06117501
Lead Sponsor Axogen Corporation
Conditions
(from sponsor)		 Recurrent Cubital Tunnel Syndrome, Recalcitrant Cubital Tunnel Syndrome
Related terms Cubital Tunnel Syndrome
Enrollment 19 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov