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Evaluation of the Auryzon™ EAR 2.0 System in Ear Reconstruction

NCT07154667 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-12-29

No results posted yet for this study

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
  • Ear Malformation
  • Ear Cartilage

Interventions

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.

Sponsors & Collaborators

  • Nemours Children's Clinic

    lead OTHER

Principal Investigators

  • Angelo A Leto Barone, MD · Nemours Children's Hospital, Florida

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-01
Primary Completion
2030-12-31
Completion
2030-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07154667 on ClinicalTrials.gov