NCT07154667 Evaluation of the Auryzon™ EAR 2.0 System in Ear Reconstruction
| NCT ID | NCT07154667 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nemours Children's Clinic |
| Condition | Microtia, Congenital |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-10-01 |
| Primary Completion | 2030-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2025-10-01 with a primary completion date of 2030-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Angelo A Leto Barone, MD
PRINCIPAL INVESTIGATOR
Nemours Children's Hospital, Florida
Frequently Asked Questions
Who can join the NCT07154667 clinical trial?
This trial is open to participants of all sexes, aged 5 Years or older, up to 20 Years, studying Microtia, Congenital. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07154667 currently recruiting?
Yes, NCT07154667 is actively recruiting participants. Contact the research team at heaven.sippio@nemours.org for enrollment information.
Where is the NCT07154667 trial being conducted?
This trial is being conducted at Orlando, United States.
Who is sponsoring the NCT07154667 clinical trial?
NCT07154667 is sponsored by Nemours Children's Clinic. The principal investigator is Angelo A Leto Barone, MD at Nemours Children's Hospital, Florida. The trial plans to enroll 30 participants.