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

Sex

ALL

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

Plain-language summary

Who can participate

Sex

ALL

See this in plain English?

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