Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2025-12-25 @ 12:27 AM
NCT ID:
NCT07154667
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
* Availability of autologous rib cartilage or consent for use of cadaveric cartilage
* Parental or legal 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 without sufficient rib cartilage for processing via the Nagata technique for auricular reconstruction and who do not desire cadaveric cartilage use
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
20 Years
Study:
NCT07154667
Study Brief:
Protocol Section:
NCT07154667