Actively Recruiting
Evaluation of the Auryzon™ EAR 2.0 System in Ear Reconstruction
Led by Nemours Children's Clinic · Updated on 2025-12-29
30
Participants Needed
1
Research Sites
273 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluation of the Auryzon™ EAR 2.0 System in Ear Reconstruction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 5 to 20 years planning to undergo surgical ear reconstruction or microtia repair under general anesthesia at Nemours Children's Hospital - Florida
- Presence of a physical deformity of the ear requiring surgical reconstruction
- Patient is healthy enough to have surgery under general anesthesia
- Parental or legal representative permission obtained; patient assent obtained when appropriate
- Ability to complete patient or parent surveys in English or Spanish
You will not qualify if you...
- Patients younger than 5 years or older than 20 years at the time of surgery
- Ear deformities that do not require surgical correction
- Surgery planned outside Nemours Children's Hospital - Florida
- Patient in poor health for general anesthesia
- Parental or legal representative permission not obtained, or patient declines assent when able
- Inability to complete surveys in English or Spanish
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Nemours Children's Hospital, Florida
Orlando, Florida, United States, 32827
Actively Recruiting
Research Team
H
Heaven Sippio - Executive Assistant
CONTACT
I
Ishpriya Sharma - Research Project Specialist, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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