Evaluation of the Auryzon™ EAR 2.0 System in Ear Reconstruction

NCT ID: NCT07154667

Last Updated: 2025-12-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2030-12-31

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.

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

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

Keywords

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Use of AuryzoN™ EAR 2.0 device

Intervention Type: PROCEDURE

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 Carved

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

Group Type: ACTIVE_COMPARATOR

Hand carving

Intervention Type: PROCEDURE

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

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.

Intervention Type: PROCEDURE

Hand carving

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

Intervention Type: PROCEDURE

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
• 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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nemours Children's Clinic

OTHER

Sponsor Role: lead

Responsible Party

Angelo Leto barone

Craniofacial and Pediatric Plastic Surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Angelo A Leto Barone, MD

Role: PRINCIPAL_INVESTIGATOR

Nemours Children's Hospital, Florida

Locations

Nemours Children's Hospital, Florida

Orlando, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Heaven Sippio - Executive Assistant

Role: CONTACT

Phone: 407-650-7358

Email: heaven.sippio@nemours.org

Ishpriya Sharma - Research Project Specialist, PhD

Role: CONTACT

Email: ishpriya.sharma@nemours.org

Facility Contacts

Heaven Sippio, Executive Assistant

Role: primary

References

Su-Genyk P, Quatela O, Quatela V. Our Evolution of Approaches to Microtia Reconstruction. Facial Plast Surg Clin North Am. 2024 Feb;32(1):105-125. doi: 10.1016/j.fsc.2023.09.002.

Reference Type: BACKGROUND

PMID: 37981407 (View on PubMed)

Tanzer RC. Microtia--a long-term follow-up of 44 reconstructed auricles. Plast Reconstr Surg. 1978 Feb;61(2):161-6. doi: 10.1097/00006534-197802000-00001.

Reference Type: BACKGROUND

PMID: 622405 (View on PubMed)

Nagata S. A new method of total reconstruction of the auricle for microtia. Plast Reconstr Surg. 1993 Aug;92(2):187-201. doi: 10.1097/00006534-199308000-00001.

Reference Type: BACKGROUND

PMID: 8337267 (View on PubMed)

Related Links

https://www.nemours.org/services/pediatric-plastic-surgery.html

Nemours Plastic Surgery Website

Other Identifiers

STUDY00000371

Identifier Type: -

Identifier Source: org_study_id