Evaluation of the Auryzon™ EAR 2.0 System in Ear Reconstruction
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 me
| Condition(s) | Microtia, Congenital, Microtia, Microtia-Anotia, Ear Deformities, Acquired, Ear Deformity External, Ear Malformation, Ear Cartilage |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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. |
| Who can participate | 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 |
| Ages | 5 Years to 20 Years |
| Sex | All |
| Lead sponsor | Nemours Children's Clinic |
| Locations | Orlando, Florida, United States |
| Start date | 2025-10-01 |
| NCT ID | NCT07154667 |
| Official listing | https://clinicaltrials.gov/study/NCT07154667 |