- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03624608
Evaluation of the Auryzon Devices in the Optimization of Ear and Nose Reconstruction Procedures
Evaluation of the Auryzon Family of Cartilage Processing Devices in the Optimization of Cartilaginous Reconstructions
Study Overview
Status
Conditions
- Microtia
- Ear Deformities, Acquired
- Ear; Deformity, Congenital
- Nose Deformity
- Nose Deformities, Acquired
- Nose; Deformity, Congenital
- Nose; Deformity, Congenital, Bent or Squashed
- Nose; Deformity, Syphilitic, Congenital
- Nose; Deformity, Bone (Nose Cartilage)
- Nose; Deformity, Septum, Congenital
- Nose; Deformity, Sinus (Wall), Congenital
- Nose; Deformity, Syphilitic, Late (Etiology)
- Ear; Deformity, External
- Ear; Deformity, Auricle, Ear, Acquired
- Ear; Deformity, Auricle, Ear (Congenital)
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Angelo Leto Barone
- Phone Number: 6672240758
- Email: aletobarone@reconstrata.com
Study Locations
-
-
Ohio
-
Cincinnati, Ohio, United States, 45229
- Cincinnati Children's Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Auryzon-Processed Ear/Nose
Patients in this category underwent reconstruction and implantation of a completed ear/nose cartilaginous graft that was processed using the AuryzoN device.
|
The AuryzoN family of devices includes a longitudinal cartilage trimmer (DimensioN) and 2D shape carving machine with custom blades (AuryzoN).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total cartilage processing time
Time Frame: Three years (until 2023)
|
Total operative time spent by the surgeon preparing cartilage substrate into finished structures
|
Three years (until 2023)
|
Objective Quality of Reconstruction
Time Frame: Up to 1 year post-op (until 2023)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total operative time
Time Frame: Three years (until 2023)
|
Total operative time by the surgeon performing the reconstructive surgery
|
Three years (until 2023)
|
Cartilage processing error rate
Time Frame: Three years (until 2023)
|
Number of errors (defined as anatomic deviations) incurred during cartilaginous processing
|
Three years (until 2023)
|
Patient satisfaction
Time Frame: Up to 1 year post-op (until 2023)
|
Subjective survey completed by patients asking about satisfaction with reconstruction
|
Up to 1 year post-op (until 2023)
|
Subjective Quality of Reconstruction
Time Frame: Up to 1 year post-op (until 2023)
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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)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Angelo Leto Barone, Reconstrata, LLC
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AZN-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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