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 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.

NCT Number	NCT07154667
Lead Sponsor	Nemours Children's Clinic
Conditions	Microtia, Congenital, Microtia, Microtia-Anotia, Ear Deformities, Acquired, Ear Deformity External, Ear Malformation, Ear Cartilage
Enrollment	30 participants
Start Date	2025-10-01
Primary Completion	2030-12-31 (estimated)
Study Completion	2030-12-31 (estimated)
Updated on ClinicalTrials.gov	2025-12-29