Microtia, CongenitalNCT07154667
Evaluation of the Auryzon™ EAR 2.0 System in Ear Reconstruction
A study testing Use of AuryzoN™ EAR 2.0 device and Hand carving in people with Microtia, Congenital and Microtia, run by Nemours Children's Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 20 years
- Conditions the study is for
- Microtia, Congenital, Microtia, Microtia-Anotia
- What is being tested?
- Use of AuryzoN™ EAR 2.0 device and Hand carving
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2025to 31 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ishpriya Sharma - Research Project Specialist, PhD contact
United States1 site, 1 recruiting
- Recruiting
Nemours Children's Hospital, Florida
Orlando, Florida, 32827
Heaven Sippio, Executive Assistant, 407-650-7358, heaven.sippio@nemours.org
Angelo A Leto Barone, MD
About this study
Official title: Enhancing Cartilaginous Ear Reconstruction - An Institutional Outcomes Study
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.
Read the 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
- Being tested
- Use of AuryzoN™ EAR 2.0 device, Hand carving
- Keywords
- microtia, ear reconstruction, craniofacial difference, anotia, plastic surgery, ear defect, ear trauma, ear deficit
- Medical subject headings
- Congenital Microtia, Microtia-Anotia, Ear Deformities, Acquired
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of AuryzoN™ EAR 2.0 deviceProcedure or surgery
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 carvingProcedure or surgery
Standard hand carving using standard surgical blades will be performed in this intervention arm of the study.
| Study group | Role | What they receive |
|---|---|---|
| AuryzoN™ EAR 2.0 arm | Experimental | Participants in the AuryzoN™ EAR 2.0 arm will receive ear reconstruction surgery using the AuryzoN™ EAR 2.0 device Receives: Procedure: Use of AuryzoN™ EAR 2.0 device |
| Hand Carved | Active comparator | Participants in this arm will receive ear reconstruction surgery using the hand carved technique Receives: Procedure: Hand carving |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Parents and patients (over age 12) will complete a four-question survey asking how much they like: the shape of the new ear, how the new ear looks, how natural the new ear looks, and the new ear overall. Participants will respond to each question with a rating from 1-5, with 1 being "do not like it at all" and 5 being "like it very much". Investigators will compare the responses from the hand-carved cohort and the AuryzoN™ EAR 2.0 cohort to determine which has more favorable outcomes.
Measured: From the beginning of the study to the end at 5 years
Evaluating reduction in operative time between the two techniques.
Compare changes in operative time between participants enrolled in the AuryzoN™ EAR 2.0 arm and the traditional hand-carving arm.
Measured: From the beginning of the study to the end at 5 years
Evaluating reduction in assembly time between the two techniques.
Compare the assembly time of cartilage into the ear construct between the AuryzoN™ EAR 2.0 arm and the hand-carving technique.
Measured: From the beginning of the study to the end at 5 years
Evaluating reduction in wire usage between the two techniques
Compare the amount of wire required for assembly of the ear construct between the Auryzon™ EAR 2.0 arm and the hand-carving technique.
Measured: From the beginning of the study to the end at 5 years
Evaluation of cartilage stability
Assess cartilage framework stability over 12 months post-surgically using photography, measurements, 3D imaging, and histopathological analysis.
Measured: From the beginning of the study to the end at 5 years
Evaluation of resorption rates
Assess resorption rates over 12 months post-surgically using photography, measurements, 3D imaging and histopathological analysis.
Measured: From the beginning of the study to the end at 5 years
Secondary outcomes (2)
Conduct histopathological analysis assessing outcomes of banked allogeneic cartilage between stage 1 and stage 2 surgeries
Cartilage will be banked in participants' groin or supraclavicular region during the six months between stage 1 and stage 2 ear reconstruction surgeries. Investigators will conduct histopathological analysis to assess the quality of the banked cartilage when it is recovered for use in the stage 2 surgery. This pathological analysis of the banked cartilage will be performed by using Hematoxylin \& Eosin (H\&E) staining and evaluating chondrocytes and extracellular matrix for signs of inflammatory response or rejection.
Measured: From the beginning of the study to the end at 5 years
Assessing any changes to the dimensions of the banked cartilage when it is retrieved for stage 2 reconstruction surgery.
Surgeons will measure the dimensions of the cartilage before banking at the end of the stage 1 surgery and after retrieving the banked cartilage during the stage 2 surgery. Investigators will compare the dimensions of the cartilage before and after banking to determine whether there are any signing or warping or resorption
Measured: From the beginning of the study to the end at 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start1 Oct 2025
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Microtia, CongenitalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nemours Children's Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angelo Leto barone, Nemours Children's Clinic
- Investigators
- Angelo A Leto Barone, MD, Principal investigator, Nemours Children's Hospital, Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07154667
- Sponsor's protocol ID
- STUDY00000371
- Status last verified
- Dec 2025
- First submitted
- 15 Aug 2025
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 8337267Tanzer 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.
PubMed 622405Su-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.
PubMed 37981407
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Cartilaginous Ear Reconstruction - An Institutional Outcomes Study
- ClinicalTrials.gov ID
- NCT07154667
- Acronym / sponsor ID
- STUDY00000371
- Conditions
- Microtia, Congenital, Microtia, Microtia-Anotia, Ear Deformities, Acquired, Ear Deformity External, Ear Malformation
- Keywords
- microtia, ear reconstruction, craniofacial difference, anotia, plastic surgery, ear defect, ear trauma, ear deficit
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Nemours Children's ClinicUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 4 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AuryzoN™ EAR 2.0 arm | Experimental | Procedure: Use of AuryzoN™ EAR 2.0 deviceParticipants in the AuryzoN™ EAR 2.0 arm will receive ear reconstruction surgery using the AuryzoN™ EAR 2.0 device |
| Hand Carved | Active comparator | Procedure: Hand carvingParticipants in this arm will receive ear reconstruction surgery using the hand carved technique |
Who may qualify
- Ages
- 5 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of AuryzoN™ EAR 2.0 deviceAuryzoN™ 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 or surgery | AuryzoN™ EAR 2.0 arm |
| Hand carvingStandard hand carving using standard surgical blades will be performed in this intervention arm of the study. | Procedure or surgery | Hand Carved |
Primary outcome
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
Parents and patients (over age 12) will complete a four-question survey asking how much they like: the shape of the new ear, how the new ear looks, how natural the new ear looks, and the new ear overall. Participants will respond to each question with a rating from 1-5, with 1 being "do not like it at all" and 5 being "like it very much". Investigators will compare the responses from the hand-carved cohort and the AuryzoN™ EAR 2.0 cohort to determine which has more favorable outcomes.
Evaluating reduction in operative time between the two techniques.
Time frame: From the beginning of the study to the end at 5 years
Compare changes in operative time between participants enrolled in the AuryzoN™ EAR 2.0 arm and the traditional hand-carving arm.
Evaluating reduction in assembly time between the two techniques.
Time frame: From the beginning of the study to the end at 5 years
Compare the assembly time of cartilage into the ear construct between the AuryzoN™ EAR 2.0 arm and the hand-carving technique.
Evaluating reduction in wire usage between the two techniques
Time frame: From the beginning of the study to the end at 5 years
Compare the amount of wire required for assembly of the ear construct between the Auryzon™ EAR 2.0 arm and the hand-carving technique.
Evaluation of cartilage stability
Time frame: From the beginning of the study to the end at 5 years
Assess cartilage framework stability over 12 months post-surgically using photography, measurements, 3D imaging, and histopathological analysis.
Evaluation of resorption rates
Time frame: From the beginning of the study to the end at 5 years
Assess resorption rates over 12 months post-surgically using photography, measurements, 3D imaging and histopathological analysis.
2 secondary outcomes
Conduct histopathological analysis assessing outcomes of banked allogeneic cartilage between stage 1 and stage 2 surgeries
Time frame: From the beginning of the study to the end at 5 years
Assessing any changes to the dimensions of the banked cartilage when it is retrieved for stage 2 reconstruction surgery.
Time frame: From the beginning of the study to the end at 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
- Background: PubMed 8337267Nagata 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.
- Background: PubMed 622405Tanzer 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.
- Background: PubMed 37981407Su-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.
- Nemours Plastic Surgery WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ishpriya Sharma - Research Project Specialist, PhD contact
Angelo A Leto Barone, MD principal investigator
Nemours Children's Hospital, Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of AuryzoN™ EAR 2.0 device and Hand carving in people with Microtia, Congenital and Microtia, run by Nemours Children's Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Heaven Sippio - Executive Assistant (407-650-7358, heaven.sippio@nemours.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07154667, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2025.