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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
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) Device: AuryzoN Family of Devices Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Auryzon Family of Cartilage Processing Devices in the Optimization of Cartilaginous Reconstructions
Estimated Study Start Date : March 1, 2020
Estimated Primary Completion Date : March 1, 2023
Estimated Study Completion Date : March 1, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.
 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).


Outcome Measures
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Primary Outcome Measures :
  1. Total cartilage processing time [ Time Frame: Three years (until 2023) ]
    Total operative time spent by the surgeon preparing cartilage substrate into finished structures

  2. 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.



Secondary Outcome Measures :
  1. Total operative time [ Time Frame: Three years (until 2023) ]
    Total operative time by the surgeon performing the reconstructive surgery

  2. Cartilage processing error rate [ Time Frame: Three years (until 2023) ]
    Number of errors (defined as anatomic deviations) incurred during cartilaginous processing

  3. Patient satisfaction [ Time Frame: Up to 1 year post-op (until 2023) ]
    Subjective survey completed by patients asking about satisfaction with reconstruction

  4. 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


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03624608


Contacts
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Contact: Angelo Leto Barone 6672240758 aletobarone@reconstrata.com

Locations
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United States, Maryland
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21287
Contact: Angelo Leto Barone, MD         
Sponsors and Collaborators
Reconstrata, LLC
Johns Hopkins University
Investigators
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Principal Investigator: Angelo Leto Barone Reconstrata, LLC
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Reconstrata, LLC
ClinicalTrials.gov Identifier: NCT03624608    
Other Study ID Numbers: AZN-001
First Posted: August 10, 2018    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Nose Deformities, Acquired
Congenital Microtia
Ear Deformities, Acquired
Congenital Abnormalities
 Ear Diseases
Otorhinolaryngologic Diseases
Nose Diseases
Respiratory Tract Diseases