RECRUITING

Evaluation of the Auryzon™ EAR 2.0 System in Ear Reconstruction

Description

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

Microtia, CongenitalMicrotiaMicrotia-AnotiaEar Deformities, AcquiredEar Deformity ExternalEar MalformationEar Cartilage
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Related Conditions:

Microtia, CongenitalMicrotiaMicrotia-AnotiaEar Deformities, AcquiredEar Deformity ExternalEar MalformationEar Cartilage

Study Overview

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Study Details

Study overview

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.

Enhancing Cartilaginous Ear Reconstruction - An Institutional Outcomes Study

Evaluation of the Auryzon™ EAR 2.0 System in Ear Reconstruction

Condition
Microtia, Congenital
Intervention / Treatment

-

Contacts and Locations

Orlando

Nemours Children's Hospital, Florida, Orlando, Florida, United States, 32827

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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 anesthesia
  • * Availability of autologous rib cartilage or consent for use of cadaveric cartilage
  • * Parental or legal acceptable representative (LAR) permission obtained for inclusion in the study; patient assent obtained where age-appropriate
  • * Sufficient fluency in English or Spanish to complete patient/parent surveys
  • * 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 without sufficient rib cartilage for processing via the Nagata technique for auricular reconstruction and who do not desire cadaveric cartilage use
  • * Patients determined to be in poor health to undergo surgery under general anesthesia
  • * Parental or LAR permission cannot be obtained, and/or patient of sufficient age and cognitive capacity declines to assent
  • * Lack of fluency in English or Spanish to complete patient/parent surveys

Ages Eligible for Study

5 Years to 20 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Nemours Children's Clinic,

Angelo A Leto Barone, MD, PRINCIPAL_INVESTIGATOR, Nemours Children's Hospital, Florida

Study Record Dates

2030-12-31