Evaluation of the Auryzon™ EAR 2.0 System in Ear Reconstruction

NCT07154667 | Recruiting DMC

• 1 other identifier: STUDY00000371
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Keywords

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

Outcome Measures

Primary Outcomes (6)

• Evaluate the results of patient and parent satisfaction with the constructed ear's shape and appearance and compare the results between the hand-carved cohort and the AuryzoN™ EAR 2.0 cohort using a four-question survey.

  Parents and patients (over age 12) will complete a four-question survey asking how much they like: the shape of the new ear, how the new ear looks, how natural the new ear looks, and the new ear overall. Participants will respond to each question with a rating from 1-5, with 1 being "do not like it at all" and 5 being "like it very much". Investigators will compare the responses from the hand-carved cohort and the AuryzoN™ EAR 2.0 cohort to determine which has more favorable outcomes.

  From the beginning of the study to the end at 5 years

• Evaluating reduction in operative time between the two techniques.

  Compare changes in operative time between participants enrolled in the AuryzoN™ EAR 2.0 arm and the traditional hand-carving arm.

  From the beginning of the study to the end at 5 years

• Evaluating reduction in assembly time between the two techniques.

  Compare the assembly time of cartilage into the ear construct between the AuryzoN™ EAR 2.0 arm and the hand-carving technique.

  From the beginning of the study to the end at 5 years

• Evaluating reduction in wire usage between the two techniques

  Compare the amount of wire required for assembly of the ear construct between the Auryzon™ EAR 2.0 arm and the hand-carving technique.

  From the beginning of the study to the end at 5 years

• Evaluation of cartilage stability

  Assess cartilage framework stability over 12 months post-surgically using photography, measurements, 3D imaging, and histopathological analysis.

  From the beginning of the study to the end at 5 years

• Evaluation of resorption rates

  Assess resorption rates over 12 months post-surgically using photography, measurements, 3D imaging and histopathological analysis.

  From the beginning of the study to the end at 5 years

Secondary Outcomes (2)

• Conduct histopathological analysis assessing outcomes of banked allogeneic cartilage between stage 1 and stage 2 surgeries

  From the beginning of the study to the end at 5 years

• Assessing any changes to the dimensions of the banked cartilage when it is retrieved for stage 2 reconstruction surgery.

  From the beginning of the study to the end at 5 years

Study Arms (2)

AuryzoN™ EAR 2.0 arm

EXPERIMENTAL

Participants in the AuryzoN™ EAR 2.0 arm will receive ear reconstruction surgery using the AuryzoN™ EAR 2.0 device

Procedure: Use of AuryzoN™ EAR 2.0 device

Hand Carved

ACTIVE COMPARATOR

Participants in this arm will receive ear reconstruction surgery using the hand carved technique

Procedure: Hand carving

Interventions

Use of AuryzoN™ EAR 2.0 device PROCEDURE

AuryzoN™ EAR 2.0 is an investigational non-significant risk device developed to improve cartilage construct shape and stability prior to use in ear reconstructive surgery.

AuryzoN™ EAR 2.0 arm

Hand carving PROCEDURE

Standard hand carving using standard surgical blades will be performed in this intervention arm of the study.

Hand Carved

Eligibility Criteria

• Age: 5 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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
• Sufficient fluency in English or Spanish to complete patient/parent surveys

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Nemours Children's Clinic: lead

Study Sites (1)

Nemours Children's Hospital, Florida

Orlando, Florida, 32827, United States

RECRUITING

Related Publications (3)

• Nagata S. A new method of total reconstruction of the auricle for microtia. Plast Reconstr Surg. 1993 Aug;92(2):187-201. doi: 10.1097/00006534-199308000-00001.

  PMID: 8337267 BACKGROUND

• Tanzer RC. Microtia--a long-term follow-up of 44 reconstructed auricles. Plast Reconstr Surg. 1978 Feb;61(2):161-6. doi: 10.1097/00006534-197802000-00001.

  PMID: 622405 BACKGROUND

• Su-Genyk P, Quatela O, Quatela V. Our Evolution of Approaches to Microtia Reconstruction. Facial Plast Surg Clin North Am. 2024 Feb;32(1):105-125. doi: 10.1016/j.fsc.2023.09.002.

  PMID: 37981407 BACKGROUND

Related Links

• Nemours Plastic Surgery Website

MeSH Terms

Conditions

Congenital Microtia; Microtia-Anotia; Ear Deformities, Acquired

Condition Hierarchy (Ancestors)

Ear Diseases; Otorhinolaryngologic Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Angelo A Leto Barone, MD

  Nemours Children's Hospital, Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Heaven Sippio - Executive Assistant

CONTACT

407-650-7358; heaven.sippio@nemours.org

Ishpriya Sharma - Research Project Specialist, PhD

CONTACT

ishpriya.sharma@nemours.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Craniofacial and Pediatric Plastic Surgeon

Study Record Dates

• First Submitted: August 15, 2025
• First Posted: September 4, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)