Evaluation of the Auryzon™ EAR 2.0 System in Ear Reconstruction
Enhancing Cartilaginous Ear Reconstruction - An Institutional Outcomes Study
Nemours Children's Clinic
30 participants
Oct 1, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria5
- 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 Criteria6
- 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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Interventions
AuryzoN™ EAR 2.0 is an investigational non-significant risk device developed to improve cartilage construct shape and stability prior to use in ear reconstructive surgery.
Standard hand carving using standard surgical blades will be performed in this intervention arm of the study.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07154667