Recruiting

Novel Medical Device

Sponsor:

Nemours Children's Clinic

Code:

NCT07154667

Conditions

Microtia, Congenital

Microtia

Microtia-Anotia

Ear Deformities, Acquired

Ear Deformity External

Eligibility Criteria

Sex: All

Age: 5 - 20

Healthy Volunteers: Not accepted

Interventions

Use of AuryzoN™ EAR 2.0 device

Hand carving

Study Details

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.

Conditions

Microtia, Congenital

Microtia

Microtia-Anotia

Ear Deformities, Acquired

Ear Deformity External

Study ID

NCT07154667

Start date

Oct 1, 2025

Status verified date

Dec, 2025

Completion date

Dec 31, 2030

Anticipated

Primary completion date

Dec 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5 - 20

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: AuryzoN™ EAR 2.0 arm

Participants in the AuryzoN™ EAR 2.0 arm will receive ear reconstruction surgery using the AuryzoN™ EAR 2.0 device

active comparator: Hand Carved

Participants in this arm will receive ear reconstruction surgery using the hand carved technique

Interventions

Use of AuryzoN™ EAR 2.0 device

AuryzoN™ EAR 2.0 is an investigational non-significant risk device developed to improve cartilage construct shape and stability prior to use in ear reconstructive surgery.

Hand carving

Standard hand carving using standard surgical blades will be performed in this intervention arm of the study.

Primary outcome measure

  • 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. [ Time Frame: From the beginning of the study to the end at 5 years ]
  • Evaluating reduction in operative time between the two techniques. [ Time Frame: From the beginning of the study to the end at 5 years ]
  • Evaluating reduction in assembly time between the two techniques. [ Time Frame: From the beginning of the study to the end at 5 years ]
  • Evaluating reduction in wire usage between the two techniques [ Time Frame: From the beginning of the study to the end at 5 years ]
  • Evaluation of cartilage stability [ Time Frame: From the beginning of the study to the end at 5 years ]
  • Evaluation of resorption rates [ Time Frame: From the beginning of the study to the end at 5 years ]

Central Contacts and Locations

Central contacts

Heaven Sippio - Executive Assistant

407-650-7358heaven.sippio@nemours.org

Ishpriya Sharma - Research Project Specialist, PhD

ishpriya.sharma@nemours.org

Locations

Nemours Children's Hospital, Florida

Recruiting

Orlando, Florida, United States, 32827

Contacts

Heaven Sippio, Executive Assistant

407-650-7358heaven.sippio@nemours.org

Principal Investigator:

Angelo A Leto Barone, MD

More Information

Sponsor

Nemours Children's Clinic

Last update posted

Dec 29, 2025

Last verified

Dec, 2025

Keywords

  • microtia
  • ear reconstruction
  • craniofacial difference
  • anotia
  • plastic surgery
  • ear defect
  • ear trauma
  • ear deficit

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Nemours Children's Clinic on 2025-12-29.