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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03624608
Recruitment Status : Recruiting
First Posted : August 10, 2018
Last Update Posted : February 5, 2020
Sponsor:
Collaborator:
Johns Hopkins University
Information provided by (Responsible Party):
Reconstrata, LLC

Tracking Information
First Submitted Date  ICMJE July 22, 2018
First Posted Date  ICMJE August 10, 2018
Last Update Posted Date February 5, 2020
Estimated Study Start Date  ICMJE March 1, 2020
Estimated Primary Completion Date March 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 1, 2020)
  • Total cartilage processing time [ Time Frame: Three years (until 2023) ]
    Total operative time spent by the surgeon preparing cartilage substrate into finished structures
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 6, 2018)
  • Total cartilage processing time [ Time Frame: Three years (until 2021) ]
    Total operative time spent by the surgeon preparing cartilage substrate into finished structures
  • Objective Quality of Reconstruction [ Time Frame: Up to 1 year post-op (until 2022) ]
    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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 1, 2020)
  • Total operative time [ Time Frame: Three years (until 2023) ]
    Total operative time by the surgeon performing the reconstructive surgery
  • Cartilage processing error rate [ Time Frame: Three years (until 2023) ]
    Number of errors (defined as anatomic deviations) incurred during cartilaginous processing
  • Patient satisfaction [ Time Frame: Up to 1 year post-op (until 2023) ]
    Subjective survey completed by patients asking about satisfaction with reconstruction
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: August 6, 2018)
  • Total operative time [ Time Frame: Three years (until 2021) ]
    Total operative time by the surgeon performing the reconstructive surgery
  • Cartilage processing error rate [ Time Frame: Three years (until 2021) ]
    Number of errors (defined as anatomic deviations) incurred during cartilaginous processing
  • Patient satisfaction [ Time Frame: Up to 1 year post-op (until 2022) ]
    Subjective survey completed by patients asking about satisfaction with reconstruction
  • Subjective Quality of Reconstruction [ Time Frame: Up to 1 year post-op (until 2022) ]
    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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of the Auryzon Devices in the Optimization of Ear and Nose Reconstruction Procedures
Official Title  ICMJE Evaluation of the Auryzon Family of Cartilage Processing Devices in the Optimization of Cartilaginous Reconstructions
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • 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)
Intervention  ICMJE Device: AuryzoN Family of Devices
The AuryzoN family of devices includes a longitudinal cartilage trimmer (DimensioN) and 2D shape carving machine with custom blades (AuryzoN).
Study Arms  ICMJE 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.
Intervention: Device: AuryzoN Family of Devices
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 6, 2018)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 1, 2025
Estimated Primary Completion Date March 1, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Angelo Leto Barone 6672240758 aletobarone@reconstrata.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03624608
Other Study ID Numbers  ICMJE AZN-001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Reconstrata, LLC
Study Sponsor  ICMJE Reconstrata, LLC
Collaborators  ICMJE Johns Hopkins University
Investigators  ICMJE
Principal Investigator: Angelo Leto Barone Reconstrata, LLC
PRS Account Reconstrata, LLC
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP