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Evaluation of the Auryzon™ EAR 2.0 System in Ear Reconstruction

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Eligibility criteria shortened, about 34 words
    • Secondary endpoints revised (2)
    • Study description shortened, about 49 words
    v3
  2. Start date: Aug 15, 2025 to Oct 1, 2025v2
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 aims to improve surgical outcomes for children and young adults with ear differences severe secondary to congenital conditions (like microtia, a condition where the ear is underdeveloped), trauma (such as dog bites), or surgical resections secondary to skin cancer. The investigators have developed a novel medical device to shape cartilage into pre-determined shapes that, once assembled, assists the surgeon in creating an anatomically accurate cartilaginous ear framework, reduce surgery time, and minimize wire need. Other factors that might affect the quality of surgical outcomes will be examined in clinical trial participants.
Trial Details
NCT Number NCT07154667
Lead Sponsor Nemours Children's Clinic
Conditions
(from sponsor)		 Microtia, Congenital, Microtia, Microtia-Anotia, Ear Deformities, Acquired, Ear Deformity External, Ear Malformation, Ear Cartilage
Related terms Congenital Microtia, Ear Deformities, Acquired, Microtia-Anotia
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov