Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2025-12-25 @ 10:33 PM
Study NCT ID:
NCT07154667
Status:
RECRUITING
Last Update Posted:
2025-11-19
First Post:
2025-08-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of the Auryzon™ EAR 2.0 System in Ear Reconstruction
Sponsor:
Nemours Children's Clinic
Organization:
Study Overview
Official Title:
Enhancing Cartilaginous Ear Reconstruction - An Institutional Outcomes Study
Status:
RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 allows to address congenital anomalies, such as microtia, as well as deformities due to trauma or oncologic resection by replacing like with like tissue. Autologous reconstruction involves harvesting and carving rib cartilage into subunits, which are then assembled with numerous steel wires. Current challenges of the technique include operator-dependent and inconsistent outcomes, prolonged anesthesia, need for wire or suture fixation, 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 ear framework carving.
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.
Additionally, as the interest in the use of cadaveric cartilage in clinical practice increases (to avoid donor-site morbidity, expand reconstructive options for elderly patients with traumatic or oncologic defects, and reduce both anesthesia time and cost), this study will provide valuable preliminary insight into the resorption rate of cartilaginous constructs and potential differences in resorption rate between autologous and cadaveric frameworks.
Comparing hand-carved and blade-cut techniques for both autologous and cadaveric cartilage, the study will enhance understanding of potential differences in resorption rate between these methods and cartilage sources.
This study aims to: 1. Promote framework production through precise blade-cutting, 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 instead of autologous tissue.
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 ear framework carving.
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.
Additionally, as the interest in the use of cadaveric cartilage in clinical practice increases (to avoid donor-site morbidity, expand reconstructive options for elderly patients with traumatic or oncologic defects, and reduce both anesthesia time and cost), this study will provide valuable preliminary insight into the resorption rate of cartilaginous constructs and potential differences in resorption rate between autologous and cadaveric frameworks.
Comparing hand-carved and blade-cut techniques for both autologous and cadaveric cartilage, the study will enhance understanding of potential differences in resorption rate between these methods and cartilage sources.
This study aims to: 1. Promote framework production through precise blade-cutting, 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 instead of autologous tissue.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: