Auryzon EAR 2.0 to shape cartilage for ear reconstruction
Official title: Enhancing Cartilaginous Ear Reconstruction - An Institutional Outcomes Study
Run by Nemours Children's Clinic · NCT07154667 · Data updated 2026-11-12
This test will try the Auryzon EAR 2.0 device to shape rib cartilage and help surgeons build anatomically accurate ears for children and young adults (ages 5–20) with microtia or other ear deformities.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 5 Years to 20 Years |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Nemours Children's Clinic Academic / other |
| Locations | 1 site (Orlando, Florida) |
| Status | Recruiting |
| Started | October 1, 2025 |
| Main results expected | December 31, 2030 |
| Study ends | December 31, 2030 |
| Registry record updated | December 29, 2025 |
| Trial ID | NCT07154667 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children and young adults aged 5–20 with congenital or acquired ear deformities who are healthy enough for general anesthesia and plan to have ear reconstruction at Nemours Children's Hospital Florida, with English or Spanish fluency for surveys.
✕Probably not a fit
Patients aged ≤4 or ≥21, those not healthy enough for general anesthesia, or those having reconstruction at another hospital would not be eligible and therefore would not receive potential benefit from this project.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional project uses a molded-blade device to cut and shape autologous rib cartilage into predetermined subunits that are assembled into an ear framework, with the goal of reducing manual carving and wire fixation. Participants are children and young adults with congenital or acquired ear deformities undergoing reconstruction under general anesthesia at a single pediatric center. Outcomes include framework accuracy, operative time, need for wire sutures, and other factors that influence surgical results. The protocol compares device-assisted framework creation to conventional hand-carving methods and collects patient/parent-reported data in English or Spanish.
Why it matters
Potential benefit: If successful, the device could shorten operative time, reduce the need for wire fixation, and produce more consistent, anatomically accurate ear frameworks, expanding access to satisfactory reconstructions.
How similar studies have gone: A previously published prototype using specialized blades showed promise for standardizing cartilage carving, but large clinical outcome data remain limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion 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 * 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 Criteria: * 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
Where it's running
-
Nemours Children's Hospital, Florida
Orlando, Florida, United States Recruiting
Study contacts
- Principal investigator: Angelo A Leto Barone, MD — Nemours Children's Hospital, Florida
- Study coordinator: Heaven Sippio - Executive Assistant
- Email: heaven.sippio@nemours.org
- Phone: 407-650-7358
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.