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Evaluation of the Auryzon™ EAR 2.0 System in Ear Reconstruction

RecruitingNAAges 5 Years - 20 YearsAllNemours Children's Clinic
NCT07154667 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Patients aged 5-20 years seeking to undergo surgical ear reconstruction or microtia repair under general anesthesia through NCH-FL * Pre-existing physical deformity of the ear necessitating surgical reconstruction * Patient of sufficient health to undergo surgery under general anesthesia * Parental or legally acceptable representative (LAR) permission obtained for inclusion in the study; patient assent obtained where age-appropriate * Sufficient fluency in English or Spanish to complete patient/parent surveys Exclusion Criteria: * Patients who will be ≤4 years old, or ≥21 years old at time of surgery * Patients with ear deformities do not require surgical correction * Patient's whose ear reconstruction surgery will be performed somewhere other than Nemours Children's Hospital - Florida * Patients determined to be in poor health to undergo surgery under general anesthesia * Parental or LAR permission cannot be obtained, and/or patient of sufficient age and cognitive capacity declines to assent * Lack of fluency in English or Spanish to complete patient/parent surveys
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What it tests

  • Use of AuryzoN™ EAR 2.0 device
  • Hand carving
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Where

1 site
Nemours Children's Hospital, Florida
Orlando, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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