Evaluation of the Auryzon™ EAR 2.0 System in Ear Reconstruction

Part of paid clinical trials in Orlando, Florida.

Sponsor
Nemours Children's Clinic
Study ID
NCT07154667
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
5 Years - 20 Years
Healthy Volunteers
Not accepted

Interventions

  • Use of AuryzoN™ EAR 2.0 device — 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 carving — PROCEDURE
    Standard hand carving using standard surgical blades will be performed in this intervention arm of the study.

Study Details

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.

Key Dates

Start date
Oct 1, 2025
Status verified
Dec 2025
Primary completion
Dec 31, 2030
Completion
Dec 31, 2030

Study Design

Enrollment
30 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Nemours Children's Hospital, FloridaOrlandoFlorida32827
Heaven Sippio, Executive Assistant
[email protected]
407-650-7358
Angelo A Leto Barone, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Nemours Children's Hospital, Florida· Orlando, FL

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