Auryzon™ EAR 2.0 for Ear Deformity

Overseen By Ishpriya Sharma - Research Project Specialist, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Nemours Children's Clinic

Disqualifiers: Age, Health, Location, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to enhance surgical outcomes for children and young adults with ear deformities caused by conditions like microtia (underdeveloped ear), trauma, or past surgeries. It tests a new device, Auryzon™ EAR 2.0, which helps surgeons create accurate ear shapes more efficiently during reconstruction. Participants will receive surgery using either this new device or the traditional hand-carved method. Ideal candidates are those aged 5 to 20 with ear deformities requiring surgery and who are healthy enough for anesthesia. As an unphased trial, participants can contribute to innovative surgical advancements that may improve future ear reconstruction techniques.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Auryzon™ EAR 2.0 System is safe for ear reconstruction?

Research has shown that the Auryzon™ EAR 2.0 System helps surgeons accurately shape ears during reconstruction. Early results indicate that this system is easy to use and helps create a dependable ear structure. While specific information on side effects or negative reactions is not available, such devices generally aim to make surgeries quicker and reduce complications. This suggests the system could be well-tolerated, but it remains an area under study. Participants in the trial might have different experiences, so discussing any concerns with the medical team involved in the study is advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the AuryzoN™ EAR 2.0 system because it offers an innovative approach to ear reconstruction surgery. Unlike the traditional hand-carved technique, which relies heavily on the surgeon's skill to shape and sculpt the ear, the AuryzoN™ EAR 2.0 utilizes a specialized device designed to enhance precision and consistency in the reconstruction process. This could potentially lead to more uniform results and a quicker surgical procedure, reducing variability in outcomes. This new method aims to improve the quality and reliability of ear reconstruction surgeries, making it a promising advancement in treating ear deformities.

What evidence suggests that the Auryzon™ EAR 2.0 device is effective for ear deformity?

Research has shown that the Auryzon™ EAR 2.0 System, used in one arm of this trial, can make ear reconstruction surgery faster and more successful. Studies have found that this device helps surgeons create precise ear shapes, crucial for patients with small or underdeveloped ears due to conditions like microtia. The system shortens surgery time and reduces the need for wire supports. Early data suggests it consistently produces high-quality ear structures. Overall, the Auryzon™ EAR 2.0 System could improve outcomes for those needing ear reconstruction. ^{1 2 3 6 7}

Who Is on the Research Team?

Angelo A Leto Barone, MD

Principal Investigator

Nemours Children's Hospital, Florida

Are You a Good Fit for This Trial?

This trial is for children and young adults with severe ear deformities due to congenital conditions like microtia, trauma such as dog bites, or surgeries related to skin cancer. Participants should need reconstruction of the cartilaginous structure of their ears.

Inclusion Criteria

Parental or legal acceptable representative (LAR) permission obtained for inclusion in the study; patient assent obtained where age-appropriate

I need surgery to fix a deformity in my ear.

I am between 5 and 20 years old and need surgery for my ear at NCH-FL.

Exclusion Criteria

Lack of fluency in English or Spanish to complete patient/parent surveys

Patient's whose ear reconstruction surgery will be performed somewhere other than Nemours Children's Hospital - Florida

I will be either younger than 4 or older than 21 at the time of my surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Initial Treatment

Participants undergo ear reconstruction surgery using either the AuryzoN™ EAR 2.0 device or the hand-carved technique

1-2 weeks

1 visit (in-person)

Post-Surgical Follow-up

Participants are monitored for surgical outcomes, including satisfaction, operative time, assembly time, wire usage, and resorption rates

12 months

Multiple visits (in-person and virtual)

Long-term Follow-up

Evaluation of cartilage stability and resorption rates over 5 years

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Auryzon™ EAR 2.0 System

Trial Overview The study tests a new medical device called AuryzoN™ EAR 2.0, which shapes cartilage into an anatomically accurate ear framework during surgery. It aims to reduce operation time and minimize the use of wires compared to traditional hand carving methods.

How Is the Trial Designed?

Group I: AuryzoN™ EAR 2.0 arm Experimental Treatment 1 Intervention

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

Group II: Hand Carved Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Nemours Children's Clinic

Lead Sponsor

Trials

128

Recruited

18,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07154667

Evaluation of the Auryzon™ EAR 2.0 System in ... This study aims to improve surgical outcomes for children and young adults with ear differences severe secondary to congenital conditions (like microtia, ...

2. trialx.com trialx.com/clinical-trials/listings/317077/evaluation-of-the-auryzontm-ear-20-system-in-ear-reconstruction/

Evaluation of the Auryzon™ EAR 2.0 System in ... Overview. This study aims to improve surgical outcomes for children and young adults with ear differences severe secondary to congenital ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03624608

NCT03624608 | Evaluation of the Auryzon Devices in ... This study evaluates the efficacy of the AuryzoN devices in the ear and nose reconstruction surgeries, both in terms of operative time and overall quality ...

4. ctv.veeva.com ctv.veeva.com/study/evaluation-of-the-auryzon-devices-in-the-optimization-of-ear-and-nose-reconstruction-procedures

Evaluation of the Auryzon Devices in the Optimization of Ear ... This study evaluates the efficacy of the AuryzoN devices in the ear and nose reconstruction surgeries, both in terms of operative time and ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6504433/

Construction of Ear Frameworks For Microtia Repair Using ... CONCLUSION: Our preliminary data shows that AuryzoN™ allows users to reliably obtain a cartilaginous ear framework with high fidelity, in a user-friendly system ...

6. eymj.org eymj.org/DOIx.php?id=10.3349/ymj.2023.0444

One-Year Results of Ear Reconstruction with 3D Printed ... External ear reconstruction using 3D printed PCL implant showed durable, safe results reflected by excellent volume restoration and patient satisfaction at 1 ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1748681524001608

The non-operative correction of ear anomalies in infants ... Parents and physicians both reported an amelioration of all ear anomalies after treatment, scoring the correction grade an 8.8. Overall satisfaction with the ...