Evaluation of the Auryzon™ EAR 2.0 System in Ear Reconstruction (NCT07154667) | Clinical Trial Compass
RecruitingNot Applicable
Evaluation of the Auryzon™ EAR 2.0 System in Ear Reconstruction
United States30 participantsStarted 2025-10-01
Plain-language 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.
Who can participate
Age range
5 Years – 20 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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.
Timeframe: From the beginning of the study to the end at 5 years
2
Evaluating reduction in operative time between the two techniques.
Timeframe: From the beginning of the study to the end at 5 years
3
Evaluating reduction in assembly time between the two techniques.
Timeframe: From the beginning of the study to the end at 5 years
4
Evaluating reduction in wire usage between the two techniques
Timeframe: From the beginning of the study to the end at 5 years
5
Evaluation of cartilage stability
Timeframe: From the beginning of the study to the end at 5 years
6
Evaluation of resorption rates
Timeframe: From the beginning of the study to the end at 5 years