RECRUITING

Evaluation of the Auryzon™ EAR 2.0 System in Ear Reconstruction

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Enhancing Cartilaginous Ear Reconstruction - An Institutional Outcomes Study

Quick Facts

Study Start:2025-08-15
Study Completion:2030-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07154667

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.

Ages Eligible for Study:5 Years to 20 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients aged 5-20 years seeking to undergo surgical ear reconstruction or microtia repair under general anesthesia through NCH-FL
  2. * Pre-existing physical deformity of the ear necessitating surgical reconstruction
  3. * Patient of sufficient health to undergo surgery under general anesthesia
  4. * Availability of autologous rib cartilage or consent for use of cadaveric cartilage
  5. * Parental or legal acceptable representative (LAR) permission obtained for inclusion in the study; patient assent obtained where age-appropriate
  6. * Sufficient fluency in English or Spanish to complete patient/parent surveys
  1. * Patients who will be ≤4 years old, or ≥21 years old at time of surgery
  2. * Patients with ear deformities do not require surgical correction
  3. * Patient's whose ear reconstruction surgery will be performed somewhere other than Nemours Children's Hospital - Florida
  4. * Patients without sufficient rib cartilage for processing via the Nagata technique for auricular reconstruction and who do not desire cadaveric cartilage use
  5. * Patients determined to be in poor health to undergo surgery under general anesthesia
  6. * Parental or LAR permission cannot be obtained, and/or patient of sufficient age and cognitive capacity declines to assent
  7. * Lack of fluency in English or Spanish to complete patient/parent surveys

Contacts and Locations

Study Contact

Heaven Sippio - Executive Assistant
CONTACT
407-650-7358
heaven.sippio@nemours.org
Ishpriya Sharma - Research Project Specialist, PhD
CONTACT
ishpriya.sharma@nemours.org

Principal Investigator

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

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Nemours Children's Clinic

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-15
Study Completion Date2030-12-31

Study Record Updates

Study Start Date2025-08-15
Study Completion Date2030-12-31

Terms related to this study

Keywords Provided by Researchers

  • microtia
  • ear reconstruction
  • craniofacial difference
  • anotia
  • plastic surgery
  • ear defect
  • ear trauma
  • ear deficit

Additional Relevant MeSH Terms

  • Microtia, Congenital
  • Microtia
  • Microtia-Anotia
  • Ear Deformities, Acquired
  • Ear Deformity External
  • Ear Malformation
  • Ear Cartilage