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

NCT03624608 | Terminated FDA Device

• 1 other identifier: AZN-001
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

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)

Outcome Measures

Primary Outcomes (2)

• Total cartilage processing time

  Total operative time spent by the surgeon preparing cartilage substrate into finished structures

  Three years (until 2023)

• 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 Outcomes (4)

• Total operative time

  Three years (until 2023)

• Cartilage processing error rate

  Three years (until 2023)

• Patient satisfaction

  Up to 1 year post-op (until 2023)

• Subjective Quality of Reconstruction

  Up to 1 year post-op (until 2023)

Study Arms (1)

Auryzon-Processed Ear/Nose

EXPERIMENTAL

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

Device: AuryzoN Family of Devices

Interventions

AuryzoN Family of Devices DEVICE

The AuryzoN family of devices includes a longitudinal cartilage trimmer (DimensioN) and 2D shape carving machine with custom blades (AuryzoN).

Auryzon-Processed Ear/Nose

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Reconstrata, LLC: lead
• Children's Hospital Medical Center, Cincinnati: collaborator

Study Sites (1)

Cincinnati Children's Hospital

Cincinnati, Ohio, 45229, United States

Location

Related Publications (1)

• 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.

  PMID: 33185490 DERIVED

MeSH Terms

Conditions

Ear Deformities, Acquired; Congenital Abnormalities; Congenital Microtia; Nose Deformities, Acquired; Airway Obstruction; Fistula

Condition Hierarchy (Ancestors)

Ear Diseases; Otorhinolaryngologic Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Nose Diseases; Respiratory Tract Diseases; Respiratory Insufficiency; Respiration Disorders; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Angelo Leto Barone

  Reconstrata, LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2018
• First Posted: August 10, 2018
• Study Start: March 1, 2020
• Primary Completion: January 20, 2025
• Study Completion: January 20, 2025
• Last Updated: January 23, 2025

Record last verified: 2025-01

Locations

US (1)