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

NCT03624608 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2025-01-23

No results posted yet for this study

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)

Interventions

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).

Sponsors & Collaborators

  • Children's Hospital Medical Center, Cincinnati

    collaborator OTHER

  • Reconstrata, LLC

    lead INDUSTRY

Principal Investigators

  • Angelo Leto Barone · Reconstrata, LLC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-01
Primary Completion
2025-01-20
Completion
2025-01-20
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03624608 on ClinicalTrials.gov