Clinical trial NCT03624608: Evaluation of the Auryzon Devices in the Optimization of Ear and Nose Reconstruction Procedures
Official title: Evaluation of the Auryzon Family of Cartilage Processing Devices in the Optimization of Cartilaginous Reconstructions
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: 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)
Lead sponsor: Reconstrata, LLC
Sponsor class: INDUSTRY
Collaborators: name: Children's Hospital Medical Center, Cincinnati
First posted: 2018-08-10
Enrollment: 2
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Total cartilage processing time
timeFrame: Three years (until 2023)
measure: Objective Quality of Reconstruction
timeFrame: Up to 1 year post-op (until 2023)
Secondary outcomes:
measure: Total operative time
timeFrame: Three years (until 2023)
measure: Cartilage processing error rate
timeFrame: Three years (until 2023)
measure: Patient satisfaction
timeFrame: Up to 1 year post-op (until 2023)
measure: Subjective Quality of Reconstruction
timeFrame: Up to 1 year post-op (until 2023)
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital
state: Ohio
Study officials:
affiliation: Reconstrata, LLC
name: Angelo Leto Barone
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.