Clinical Trial

Nerve Protection Evaluation: Revision Cubital Tunnel Syndrome Decompression

Study acronym: COVERED
Active, Not Recruiting
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Summary
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.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2023-11-02; most recent amendment 2025-10-02.
Status change: Recruiting → Active, Not Recruiting 2025-10-02
Trial Details
NCT Number NCT06117501
Lead Sponsor Axogen Corporation
Conditions Recurrent Cubital Tunnel Syndrome, Recalcitrant Cubital Tunnel Syndrome
Enrollment 20 participants
Start Date 2023-10-19
Primary Completion 2026-12 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2025-10-07