Status:
RECRUITING
Evaluation of the Auryzon™ EAR 2.0 System in Ear Reconstruction
Lead Sponsor:
Nemours Children's Clinic
Conditions:
Microtia, Congenital
Microtia
Eligibility:
All Genders
5-20 years
Phase:
NA
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), ...
Detailed Description
Cartilage-based ear reconstruction addresses congenital anomalies, such as microtia, as well as deformities due to trauma or oncologic resection by replacing like with like tissue. Current technique i...
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
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2030
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT07154667
Start Date
October 1 2025
End Date
December 31 2030
Last Update
December 29 2025
Active Locations (1)
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1
Nemours Children's Hospital, Florida
Orlando, Florida, United States, 32827