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Evaluation of the Auryzon™ EAR 2.0 System in Ear Reconstruction
Sponsor: Nemours Children's Clinic
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.
Official title: Enhancing Cartilaginous Ear Reconstruction - An Institutional Outcomes Study
Key Details
Gender
All
Age Range
5 Years - 20 Years
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2025-10-01
Completion Date
2030-12-31
Last Updated
2025-12-29
Healthy Volunteers
No
Conditions
Interventions
Use of AuryzoN™ EAR 2.0 device
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.
Hand carving
Standard hand carving using standard surgical blades will be performed in this intervention arm of the study.
Locations (1)
Nemours Children's Hospital, Florida
Orlando, Florida, United States