Evaluation of the Auryzon Devices in the Optimization of Ear and Nose Reconstruction Procedures
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|ClinicalTrials.gov Identifier: NCT03624608|
Recruitment Status : Recruiting
First Posted : August 10, 2018
Last Update Posted : February 5, 2020
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|Condition or disease||Intervention/treatment||Phase|
|Ear Deformities, Acquired Ear; Deformity, Congenital Microtia 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)||Device: AuryzoN Family of Devices||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of the Auryzon Family of Cartilage Processing Devices in the Optimization of Cartilaginous Reconstructions|
|Estimated Study Start Date :||March 1, 2020|
|Estimated Primary Completion Date :||March 1, 2023|
|Estimated Study Completion Date :||March 1, 2025|
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.
Device: AuryzoN Family of Devices
The AuryzoN family of devices includes a longitudinal cartilage trimmer (DimensioN) and 2D shape carving machine with custom blades (AuryzoN).
- 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.
- Total operative time [ Time Frame: Three years (until 2023) ]Total operative time by the surgeon performing the reconstructive surgery
- Cartilage processing error rate [ Time Frame: Three years (until 2023) ]Number of errors (defined as anatomic deviations) incurred during cartilaginous processing
- Patient satisfaction [ Time Frame: Up to 1 year post-op (until 2023) ]Subjective survey completed by patients asking about satisfaction with reconstruction
- Subjective Quality of Reconstruction [ Time Frame: Up to 1 year post-op (until 2023) ]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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||Child, Adult, Older Adult|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03624608
|Contact: Angelo Leto Baroneemail@example.com|
|United States, Maryland|
|Johns Hopkins Hospital||Recruiting|
|Baltimore, Maryland, United States, 21287|
|Contact: Angelo Leto Barone, MD|
|Principal Investigator:||Angelo Leto Barone||Reconstrata, LLC|
|Responsible Party:||Reconstrata, LLC|
|Other Study ID Numbers:||
|First Posted:||August 10, 2018 Key Record Dates|
|Last Update Posted:||February 5, 2020|
|Last Verified:||September 2019|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||Yes|
Nose Deformities, Acquired
Ear Deformities, Acquired
Respiratory Tract Diseases