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

  • STATUS
    Recruiting
  • End date
    Mar 1, 2025
  • participants needed
    100
  • sponsor
    Reconstrata, LLC
Updated on 26 February 2022

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.

Details
Condition 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)
Treatment AuryzoN Family of Devices
Clinical Study IdentifierNCT03624608
SponsorReconstrata, LLC
Last Modified on26 February 2022

Eligibility

Yes No Not Sure

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
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