Microtia Clinical Trial
Official title:
Evaluation of the Auryzon Family of Cartilage Processing Devices in the Optimization of Cartilaginous Reconstructions
NCT number | NCT03624608 |
Other study ID # | AZN-001 |
Secondary ID | |
Status | Suspended |
Phase | N/A |
First received | |
Last updated | |
Start date | March 1, 2020 |
Est. completion date | March 1, 2027 |
Verified date | March 2024 |
Source | Reconstrata, LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Suspended |
Enrollment | 100 |
Est. completion date | March 1, 2027 |
Est. primary completion date | March 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - Patients aged 1-100 of sufficient health required to undergo ear/nose reconstruction under general anesthesia - Pre-existing physical deformity of the ear, nose, or eyelid necessitating surgical reconstruction - Sufficient autologous or cadaveric rib cartilage for use by the AuryzoN system for cartilage processing Exclusion Criteria: - Patients with ear/nose/eyelid deformities not requiring surgical correction - Patients without sufficient rib cartilage for use by the AuryzoN system and those who do not desire cadaveric cartilage use - Patients in poor health to undergo surgery under general anesthesia - Patients whose desired ear/nose/eyelid exceeds the dimensions/shapes of those pre-fabricated blades used in the AuryzoN system |
Country | Name | City | State |
---|---|---|---|
United States | Cincinnati Children's Hospital | Cincinnati | Ohio |
Lead Sponsor | Collaborator |
---|---|
Reconstrata, LLC | Children's Hospital Medical Center, Cincinnati |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Total cartilage processing time | Total operative time spent by the surgeon preparing cartilage substrate into finished structures | Three years (until 2023) | |
Primary | 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) | |
Secondary | Total operative time | Total operative time by the surgeon performing the reconstructive surgery | Three years (until 2023) | |
Secondary | Cartilage processing error rate | Number of errors (defined as anatomic deviations) incurred during cartilaginous processing | Three years (until 2023) | |
Secondary | Patient satisfaction | Subjective survey completed by patients asking about satisfaction with reconstruction | Up to 1 year post-op (until 2023) | |
Secondary | 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) |
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