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

Reconstrata

Status: Terminated

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

Treatments: Device: AuryzoN Family of Devices

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03624608

AZN-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2 participants in 1 patient group

Auryzon-Processed Ear/Nose

Experimental group

Description:

Patients in this category underwent reconstruction and implantation of a completed ear/nose cartilaginous graft that was processed using the AuryzoN device.

Treatment:

Device: AuryzoN Family of Devices