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

Status Suspended

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.

Clinical Trial 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. ;

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)

• NCT number: NCT03624608
• Study type: Interventional
• Source: Reconstrata, LLC
• Status: Suspended
• Phase: N/A
• Start date: March 1, 2020
• Completion date: March 1, 2027