Not provided
Not provided
Not provided
Not provided
Not provided
Enrollment target not reached.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Children's Hospital Medical Center, Cincinnati | OTHER |
Not provided
Not provided
Not provided
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 of reconstruction. Research participants will undergo reconstruction either using the AuryzoN device or through current methods (traditional manual processing) at the discretion of their surgeon prior to the start of surgery.
The AuryzoN devices are a family of two (2) devices that, in conjunction, serve to process substrates of autologous-derived or cadaveric cartilage used in the reconstruction of various structures of the body, namely ear and nose. The devices are to be used in the operating room to cut and carve substrates of tissue into components, which are then assembled into the final ear or nose, that will then be implanted by the plastic surgeon into the appropriate area. This device family serves to replace the current step in this reconstructive procedure, which involves the time-consuming and error-prone process of manual cartilage processing.
Participants will be given the option to participate in the study. If the participants so choose, they will undergo ear or nose reconstruction using the AuryzoN devices or traditional manual processing at the discretion of their surgeon prior to the start of surgery. The following outcome measures will be measured: operative time, error rates, objective quality outcomes of reconstruction, subjective quality outcomes of reconstruction, and patient satisfaction.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Auryzon-Processed Ear/Nose | Experimental | Patients in this category underwent reconstruction and implantation of a completed ear/nose cartilaginous graft that was processed using the AuryzoN device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AuryzoN Family of Devices | Device | The AuryzoN family of devices includes a longitudinal cartilage trimmer (DimensioN) and 2D shape carving machine with custom blades (AuryzoN). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total cartilage processing time | Total operative time spent by the surgeon preparing cartilage substrate into finished structures | Three years (until 2023) |
| Objective Quality of Reconstruction | An objective scoring system will be developed to score ears and noses based on anatomic accuracy, and reconstructed ears/noses will be scored using this system. Scoring system scale: The following metrics will be assessed by independent observers on a scale from 0-5, with 5 indicating perfect anatomic fidelity as compared to the patient's contralateral ear (or a model ear if no contralateral ear is available) or model nose and 0 indicating complete anatomical difference or loss of that structure. The following ear and nose subcomponents will be graded: Ear: Helix, antihelix, tragus, crus, anatomical proportion of all substrates as compared to each other substrate. Nose: Septum, alar cartilages, lateral cartilages, horizontal strut, anatomical proportion of all substrates as compared to each other substrate. | Up to 1 year post-op (until 2023) |
| Measure | Description | Time Frame |
|---|---|---|
| Total operative time | Total operative time by the surgeon performing the reconstructive surgery | Three years (until 2023) |
| Cartilage processing error rate | Number of errors (defined as anatomic deviations) incurred during cartilaginous processing |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Angelo Leto Barone | Reconstrata, LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cincinnati Children's Hospital | Cincinnati | Ohio | 45229 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33185490 | Derived | Leto Barone AA, Arun A, Samaha GJ, Shallal CC, Redett RJ, Steinberg JP. Design of a Novel Reproducible Cartilage-Sparing Autologous Technique for Microtia Repair. Facial Plast Surg Aesthet Med. 2021 May-Jun;23(3):224-229. doi: 10.1089/fpsam.2020.0457. Epub 2020 Nov 12. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Three years (until 2023) |
| Patient satisfaction | Subjective survey completed by patients asking about satisfaction with reconstruction | Up to 1 year post-op (until 2023) |
| Subjective Quality of Reconstruction | Images of completed ear/nose reconstructions with the AuryzoN system will be presented to surgeons and lay-people to determine overall subjective quality of reconstruction | Up to 1 year post-op (until 2023) |
| ID | Term |
|---|---|
| D004426 | Ear Deformities, Acquired |
| D000013 | Congenital Abnormalities |
| D065817 | Congenital Microtia |
| D009667 | Nose Deformities, Acquired |
| D000402 | Airway Obstruction |
| D005402 | Fistula |
| ID | Term |
|---|---|
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012131 | Respiratory Insufficiency |
| D012120 | Respiration Disorders |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided