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

March 5, 2024 updated by: Reconstrata, LLC

Evaluation of the Auryzon Family of Cartilage Processing Devices in the Optimization of Cartilaginous Reconstructions

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Cincinnati Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Auryzon-Processed Ear/Nose
Patients in this category underwent reconstruction and implantation of a completed ear/nose cartilaginous graft that was processed using the AuryzoN device.
The AuryzoN family of devices includes a longitudinal cartilage trimmer (DimensioN) and 2D shape carving machine with custom blades (AuryzoN).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total cartilage processing time
Time Frame: Three years (until 2023)
Total operative time spent by the surgeon preparing cartilage substrate into finished structures
Three years (until 2023)
Objective Quality of Reconstruction
Time Frame: Up to 1 year post-op (until 2023)

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total operative time
Time Frame: Three years (until 2023)
Total operative time by the surgeon performing the reconstructive surgery
Three years (until 2023)
Cartilage processing error rate
Time Frame: Three years (until 2023)
Number of errors (defined as anatomic deviations) incurred during cartilaginous processing
Three years (until 2023)
Patient satisfaction
Time Frame: Up to 1 year post-op (until 2023)
Subjective survey completed by patients asking about satisfaction with reconstruction
Up to 1 year post-op (until 2023)
Subjective Quality of Reconstruction
Time Frame: Up to 1 year post-op (until 2023)
Images of completed ear/nose reconstructions with the AuryzoN system will be presented to surgeons and lay-people to determine overall subjective quality of reconstruction
Up to 1 year post-op (until 2023)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Angelo Leto Barone, Reconstrata, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2020

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

July 22, 2018

First Submitted That Met QC Criteria

August 6, 2018

First Posted (Actual)

August 10, 2018

Study Record Updates

Last Update Posted (Actual)

March 8, 2024

Last Update Submitted That Met QC Criteria

March 5, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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