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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065817', 'term': 'Congenital Microtia'}, {'id': 'C563457', 'term': 'Microtia-Anotia'}, {'id': 'D004426', 'term': 'Ear Deformities, Acquired'}], 'ancestors': [{'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2025-08-15', 'studyFirstSubmitQcDate': '2025-08-26', 'lastUpdatePostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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.", 'timeFrame': 'From the beginning of the study to the end at 5 years', 'description': '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.'}, {'measure': 'Evaluating reduction in operative time between the two techniques.', 'timeFrame': 'From the beginning of the study to the end at 5 years', 'description': 'Compare changes in operative time between participants enrolled in the AuryzoN™ EAR 2.0 arm and the traditional hand-carving arm.'}, {'measure': 'Evaluating reduction in assembly time between the two techniques.', 'timeFrame': 'From the beginning of the study to the end at 5 years', 'description': 'Compare the assembly time of cartilage into the ear construct between the AuryzoN™ EAR 2.0 arm and the hand-carving technique.'}, {'measure': 'Evaluating reduction in wire usage between the two techniques', 'timeFrame': 'From the beginning of the study to the end at 5 years', 'description': 'Compare the amount of wire required for assembly of the ear construct between the Auryzon™ EAR 2.0 arm and the hand-carving technique.'}, {'measure': 'Evaluation of cartilage stability', 'timeFrame': 'From the beginning of the study to the end at 5 years', 'description': 'Assess cartilage framework stability over 12 months post-surgically using photography, measurements, 3D imaging, and histopathological analysis.'}, {'measure': 'Evaluation of resorption rates', 'timeFrame': 'From the beginning of the study to the end at 5 years', 'description': 'Assess resorption rates over 12 months post-surgically using photography, measurements, 3D imaging and histopathological analysis.'}], 'secondaryOutcomes': [{'measure': 'Conduct histopathological analysis comparing outcomes of banked autologous versus allogeneic cartilage between stage 1 and stage 2 surgeries', 'timeFrame': 'From the beginning of the study to the end at 5 years', 'description': "Cartilage will be banked in participants' groin or chest 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. Investigators will then compare the histopathological outcomes of the autologous cartilage versus the allogeneic cartilage."}, {'measure': 'Assessing any changes to the dimensions of the banked cartilage when it is retrieved for stage 2 reconstruction surgery.', 'timeFrame': 'From the beginning of the study to the end at 5 years', 'description': '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'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['microtia', 'ear reconstruction', 'craniofacial difference', 'anotia', 'plastic surgery', 'ear defect', 'ear trauma', 'ear deficit'], 'conditions': ['Microtia, Congenital', 'Microtia', 'Microtia-Anotia', 'Ear Deformities, Acquired', 'Ear Deformity External', 'Ear Malformation', 'Ear Cartilage']}, 'referencesModule': {'references': [{'pmid': '8337267', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '622405', 'type': 'BACKGROUND', 'citation': 'Tanzer 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.'}, {'pmid': '37981407', 'type': 'BACKGROUND', 'citation': 'Su-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.'}], 'seeAlsoLinks': [{'url': 'https://www.nemours.org/services/pediatric-plastic-surgery.html', 'label': 'Nemours Plastic Surgery Website'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nGiven 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.\n\nIf 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.\n\nAdditionally, 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.\n\nComparing 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.\n\nThis 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '20 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients aged 5-20 years seeking to undergo surgical ear reconstruction or microtia repair under general anesthesia through NCH-FL\n* Pre-existing physical deformity of the ear necessitating surgical reconstruction\n* Patient of sufficient health to undergo surgery under general anesthesia\n* Availability of autologous rib cartilage or consent for use of cadaveric cartilage\n* Parental or legal acceptable representative (LAR) permission obtained for inclusion in the study; patient assent obtained where age-appropriate\n* Sufficient fluency in English or Spanish to complete patient/parent surveys\n\nExclusion Criteria:\n\n* Patients who will be ≤4 years old, or ≥21 years old at time of surgery\n* Patients with ear deformities do not require surgical correction\n* Patient's whose ear reconstruction surgery will be performed somewhere other than Nemours Children's Hospital - Florida\n* Patients without sufficient rib cartilage for processing via the Nagata technique for auricular reconstruction and who do not desire cadaveric cartilage use\n* Patients determined to be in poor health to undergo surgery under general anesthesia\n* Parental or LAR permission cannot be obtained, and/or patient of sufficient age and cognitive capacity declines to assent\n* Lack of fluency in English or Spanish to complete patient/parent surveys"}, 'identificationModule': {'nctId': 'NCT07154667', 'briefTitle': 'Evaluation of the Auryzon™ EAR 2.0 System in Ear Reconstruction', 'organization': {'class': 'OTHER', 'fullName': "Nemours Children's Clinic"}, 'officialTitle': 'Enhancing Cartilaginous Ear Reconstruction - An Institutional Outcomes Study', 'orgStudyIdInfo': {'id': 'STUDY00000371'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AuryzoN™ EAR 2.0 arm', 'description': 'Participants in the AuryzoN™ EAR 2.0 arm will receive ear reconstruction surgery using the AuryzoN™ EAR 2.0 device', 'interventionNames': ['Procedure: Use of AuryzoN™ EAR 2.0 device']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Hand Carved', 'description': 'Participants in this arm will receive ear reconstruction surgery using the hand carved technique', 'interventionNames': ['Procedure: Hand carving']}], 'interventions': [{'name': 'Use of AuryzoN™ EAR 2.0 device', 'type': 'PROCEDURE', 'description': '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.', 'armGroupLabels': ['AuryzoN™ EAR 2.0 arm']}, {'name': 'Hand carving', 'type': 'PROCEDURE', 'description': 'Standard hand carving using standard surgical blades will be performed in this intervention arm of the study.', 'armGroupLabels': ['Hand Carved']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32827', 'city': 'Orlando', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Heaven Sippio, Executive Assistant', 'role': 'CONTACT', 'email': 'heaven.sippio@nemours.org', 'phone': '407-650-7358'}, {'name': 'Angelo A Leto Barone, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Nemours Children's Hospital, Florida", 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}], 'centralContacts': [{'name': 'Heaven Sippio - Executive Assistant', 'role': 'CONTACT', 'email': 'heaven.sippio@nemours.org', 'phone': '407-650-7358'}, {'name': 'Ishpriya Sharma - Research Project Specialist, PhD', 'role': 'CONTACT', 'email': 'ishpriya.sharma@nemours.org'}], 'overallOfficials': [{'name': 'Angelo A Leto Barone, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Nemours Children's Hospital, Florida"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Nemours Children's Clinic", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Craniofacial and Pediatric Plastic Surgeon', 'investigatorFullName': 'Angelo Leto barone', 'investigatorAffiliation': "Nemours Children's Clinic"}}}}