TerminatedNot Applicable

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

Stopped: Enrollment target not reached.

United States2 participantsStarted 2020-03-01

Plain-language 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.

Who can participate

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Total cartilage processing time

Timeframe: Three years (until 2023)

Objective Quality of Reconstruction

Timeframe: Up to 1 year post-op (until 2023)

Trial details

NCT IDNCT03624608

SponsorReconstrata, LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-01-20

View on ClinicalTrials.gov More Ear Deformities, Acquired trials