NCT07154667

Evaluation of the Auryzon™ EAR 2.0 System in Ear Reconstruction

Enhancing Cartilaginous Ear Reconstruction - An Institutional Outcomes Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Nemours Children's Clinic · Academic / Other
• Sex: All
• Age: 5 Years – 20 Years
• Healthy volunteers: Not accepted

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.

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 involves the use of the autologous cartilage as the gold standard and involves harvesting patient's own rib cartilage and carving them into different ear subunits, which are then assembled with numerous steel wires. Challenges of this technique include high operator-dependency due to extensive carving, inconsistent outcomes, prolonged anesthesia, and need for wire or suture fixation, leading to wire extrusion, cartilage resorption, and overall high cost. The previously published prototype device utilized specialized blades to standardize this process. Given the complexity of auricular reconstruction and the suboptimal outcomes by most plastic surgeons globally, there is a pressing need for a standardized, enhanced and accessible method for an accurate ear framework. If successful, this project has the potential to improve plastic surgeons' technical proficiency in producing anatomically accurate auricular frameworks. Achieving these aims could substantially advance reconstructive clinical techniques in clinical practice and broaden access to satisfactory ear reconstruction beyond the limited number of highly specialized centers. Furthermore, the novel blade design has the potential to reduce the need for wire suturing, while also reducing overall framework production time, anesthesia duration, and costs. Comparing hand-carved and blade-cut techniques for cadaveric cartilage, the study will enhance understanding of potential differences in resorption rate between these methods. This study aims to: 1. Promote framework production through precise bladecutting, facilitating the construction of cartilaginous ear frameworks while improving outcomes and reducing operative time and costs; 2. Standardize framework production independently of operator skill. 3. Reduce the number of wires required for construct fixation, further contributing to decreased operative time and cost; 4. Minimize the risk of wire extrusion by limiting wires usage during framework production through the novel blade design. 5. Compare differences in framework appearance, stability, time to production, operative time, intraoperative morbidity, and construct resorption within the first year postoperatively when using cadaveric cartilage.

Conditions

• Microtia, Congenital
• Microtia
• Microtia-Anotia
• Ear Deformities, Acquired
• Ear Deformity External
• Ear Malformation
• Ear Cartilage

Interventions

Type	Name	Description
PROCEDURE	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.
PROCEDURE	Hand carving	Standard hand carving using standard surgical blades will be performed in this intervention arm of the study.

Timeline

• Start date: 2025-10-01
• Primary completion: 2030-12-31
• Completion: 2030-12-31
• First posted: 2025-09-04
• Last updated: 2025-12-29

Locations

1 site across 1 country: United States