Evaluation of the Auryzon™ EAR 2.0 System in Ear Reconstruction

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-20
SponsorNemours Children's Clinic

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, 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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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 Hospital - Florida

Patients determined to be in poor health to undergo surgery under general anesthesia

Trial design

Treatments tested in this trial

  • Use of AuryzoN™ EAR 2.0 device
  • Hand carving

Treatment groups

30 Participants
are divided into 2 treatment groups

Sponsors and collaborators