Evaluation of the Auryzon™ EAR 2.0 System in Ear Reconstruction
Recruiting
N/A
Interventional Study
Microtia, Congenital
Microtia
Microtia-Anotia
Ear Deformities, Acquired
Ear Deformity External
Ear Malformation
Ear Cartilage
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 5 – 20
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 30 (estimated)
- Sponsor
- Nemours Children's Clinic · Other
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About This Trial
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,…
Trial Locations
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Eligibility Criteria
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…
Contacts