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Auryzon™ EAR 2.0 System for Ear Reconstruction

This study is evaluating a new device called the Auryzon™ EAR 2.0 System, which helps shape cartilage for ear reconstruction surgery. This device is being compared to the standard method of hand carving cartilage. The goal is to see if the Auryzon™ EAR 2.0 System can improve the shape and appearance of the reconstructed ear, reduce surgery time, and make the process more consistent. You may be able to join if you are between 5 and 20 years old and need ear reconstruction due to conditions like microtia (underdeveloped ear), trauma, or skin cancer removal. The study will measure patient and parent satisfaction with the ear's appearance and how long the surgery takes. The current status of this study is unclear.

Study design
This interventional study plans to enroll 30 participants. It compares two techniques for ear reconstruction: using the Auryzon™ EAR 2.0 device versus standard hand carving.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 5 years to evaluate the results of the constructed ear's shape and appearance, and to assess operative and assembly times.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07154667

Evaluation of the Auryzon™ EAR 2.0 System in Ear Reconstruction

Recruiting
NAAges 5–20InterventionalTreatment
Nemours Children's Clinic
~30 participants
Updated 2025-12-29 on ClinicalTrials.gov
What's tested:Use of AuryzoN™ EAR 2.0 deviceHand carving

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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.
Measured over From the beginning of the study to the end at 5 years
+5 more outcomes measured

Conditions

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

Explore related trials

Congenital absence of external earLop ear deformityMicrotia

Where it's being run

1 sites across 1 states
Florida1

Study leadership

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

Who to contact

Heaven Sippio - Executive Assistant
[email protected]
407-650-7358
Email the study team

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Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

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

    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.

  • Evaluating reduction in operative time between the two techniques.From the beginning of the study to the end at 5 years

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

  • Evaluating reduction in assembly time between the two techniques.From the beginning of the study to the end at 5 years

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

  • Evaluating reduction in wire usage between the two techniquesFrom the beginning of the study to the end at 5 years

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

  • Evaluation of cartilage stabilityFrom the beginning of the study to the end at 5 years

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

  • Evaluation of resorption ratesFrom the beginning of the study to the end at 5 years

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