Ear Deformities, AcquiredNCT03624608
Evaluation of the Auryzon Devices in the Optimization of Ear and Nose Reconstruction Procedures
A study testing AuryzoN Family of Devices in people with Ear Deformities, Acquired and Ear; Deformity, Congenital, run by Reconstrata, LLC at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ear Deformities, Acquired, Ear; Deformity, Congenital, Microtia
- What is being tested?
- AuryzoN Family of Devices
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2020to 20 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
About this study
Official title: Evaluation of the Auryzon Family of Cartilage Processing Devices in the Optimization of Cartilaginous Reconstructions
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.
Read the 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.
- Conditions
- Ear Deformities, Acquired, Ear; Deformity, Congenital, Microtia, Nose Deformity, Nose Deformities, Acquired, Nose; Deformity, Congenital
- Being tested
- AuryzoN Family of Devices
- Medical subject headings
- Ear Deformities, Acquired, Congenital Abnormalities, Congenital Microtia, Nose Deformities, Acquired, Airway Obstruction, Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AuryzoN Family of DevicesDevice
The AuryzoN family of devices includes a longitudinal cartilage trimmer (DimensioN) and 2D shape carving machine with custom blades (AuryzoN).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: AuryzoN Family of Devices |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total cartilage processing time
Total operative time spent by the surgeon preparing cartilage substrate into finished structures
Measured: 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.
Measured: Up to 1 year post-op (until 2023)
Secondary outcomes (4)
Total operative time
Total operative time by the surgeon performing the reconstructive surgery
Measured: Three years (until 2023)
Cartilage processing error rate
Number of errors (defined as anatomic deviations) incurred during cartilaginous processing
Measured: Three years (until 2023)
Patient satisfaction
Subjective survey completed by patients asking about satisfaction with reconstruction
Measured: 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
Measured: Up to 1 year post-op (until 2023)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2018
- Study start1 Mar 2020
- Primary completion20 Jan 2025
- Study completion20 Jan 2025
Why it stopped: Enrollment target not reached.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ear Deformities, AcquiredStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reconstrata, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Children's Hospital Medical Center, Cincinnati
- Responsible party
- Sponsor
- Investigators
- Angelo Leto Barone, Principal investigator, Reconstrata, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03624608
- Sponsor's protocol ID
- AZN-001
- Status last verified
- Jan 2025
- First submitted
- 22 Jul 2018
- Last updated
- 23 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 33185490
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Auryzon Family of Cartilage Processing Devices in the Optimization of Cartilaginous Reconstructions
- ClinicalTrials.gov ID
- NCT03624608
- Acronym / sponsor ID
- AZN-001
- Conditions
- Ear Deformities, Acquired, Ear; Deformity, Congenital, Microtia, Nose Deformity, Nose Deformities, Acquired, Nose; Deformity, Congenital
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment target not reached.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Reconstrata, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Children's Hospital Medical Center, Cincinnati
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 20 Jan 2025 (actual)
- Study completion
- 20 Jan 2025 (actual)
- First posted
- 10 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Auryzon-Processed Ear/Nose | Experimental | Device: AuryzoN Family of DevicesPatients in this category underwent reconstruction and implantation of a completed ear/nose cartilaginous graft that was processed using the AuryzoN device. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AuryzoN Family of DevicesThe AuryzoN family of devices includes a longitudinal cartilage trimmer (DimensioN) and 2D shape carving machine with custom blades (AuryzoN). | Device | Auryzon-Processed Ear/Nose |
Primary outcome
Total cartilage processing time
Time frame: Three years (until 2023)
Total operative time spent by the surgeon preparing cartilage substrate into finished structures
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.
4 secondary outcomes
Total operative time
Time frame: Three years (until 2023)
Cartilage processing error rate
Time frame: Three years (until 2023)
Patient satisfaction
Time frame: Up to 1 year post-op (until 2023)
Subjective Quality of Reconstruction
Time frame: Up to 1 year post-op (until 2023)
Results and safety
The study was stopped early (reason given: Enrollment target not reached.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2025.
- Derived from this study: PubMed 33185490Leto 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angelo Leto Barone principal investigator
Reconstrata, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AuryzoN Family of Devices in people with Ear Deformities, Acquired and Ear; Deformity, Congenital, run by Reconstrata, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Enrollment target not reached.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total cartilage processing time (time frame: Three years (until 2023)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03624608, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2025.