Evaluation of the Auryzon Devices in the Optimization of Ear and Nose Reconstruction Procedures

Microtia Clinical Trial

Official title:

Evaluation of the Auryzon Family of Cartilage Processing Devices in the Optimization of Cartilaginous Reconstructions

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03624608
• Other study ID #: AZN-001
• Status: Suspended
• Phase: N/A
• Start date: March 1, 2020
• Est. completion date: March 1, 2027

Study information

• Verified date: March 2024
• Source: Reconstrata, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 the discretion of their surgeon prior to the start of surgery.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Congenital Abnormalities
• Ear Deformities, Acquired
• Ear; Deformity, Auricle, Ear (Congenital)
• Ear; Deformity, Auricle, Ear, Acquired
• Ear; Deformity, Congenital
• Ear; Deformity, External
• Microtia
• Nose Deformities, Acquired
• Nose Deformity
• Nose; Deformity, Bone (Nose Cartilage)
• Nose; Deformity, Congenital
• Nose; Deformity, Congenital, Bent or Squashed
• Nose; Deformity, Septum, Congenital
• Nose; Deformity, Sinus (Wall), Congenital
• Nose; Deformity, Syphilitic, Congenital
• Nose; Deformity, Syphilitic, Late (Etiology)

Intervention

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).

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Reconstrata, LLC	Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

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)