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AuryzoN Devices for Ear and Nose Reconstruction

N/A

Waitlist Available

Led By Angelo Leto Barone

Research Sponsored by Reconstrata, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year post-op (until 2023)

Awards & highlights

Study Summary

This trial will compare the AuryzoN devices to current methods in terms of operative time and quality of reconstruction in patients undergoing ear and nose reconstruction surgery.

Who is the study for?

This trial is for people aged 1-100 who need ear or nose reconstruction surgery and are healthy enough for general anesthesia. They must have enough of their own or donor rib cartilage to use with the AuryzoN device. It's not for those whose deformities don't need surgery, lack sufficient cartilage, are in poor health, or have reconstruction needs that exceed what AuryzoN can handle.Check my eligibility

What is being tested?

The study tests the AuryzoN devices' effectiveness in reconstructing ears and noses compared to traditional manual methods. Participants will be assigned randomly to either use the new device or undergo current surgical techniques based on their surgeon's decision before surgery starts.See study design

What are the potential side effects?

While specific side effects aren't listed for using AuryzoN devices, typical risks may include pain at the surgery site, infection, bleeding, scarring, and possible dissatisfaction with cosmetic outcomes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am healthy enough for surgery under general anesthesia.

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I need surgery to fix a deformity in my ear, nose, or eyelid.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year post-op (until 2023)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year post-op (until 2023)

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year post-op (until 2023) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Objective Quality of Reconstruction

Total cartilage processing time

Secondary outcome measures

Cartilage processing error rate

Patient satisfaction

Subjective Quality of Reconstruction

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Auryzon-Processed Ear/NoseExperimental Treatment1 Intervention

Patients in this category underwent reconstruction and implantation of a completed ear/nose cartilaginous graft that was processed using the AuryzoN device.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Children's Hospital Medical Center, CincinnatiOTHER

815 Previous Clinical Trials

6,531,496 Total Patients Enrolled

Reconstrata, LLCLead Sponsor

Johns Hopkins UniversityOTHER

2,259 Previous Clinical Trials

14,820,553 Total Patients Enrolled

Media Library

AuryzoN Family of Devices (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03624608 — N/A

Bent or Squashed Nose Research Study Groups: Auryzon-Processed Ear/Nose

Bent or Squashed Nose Clinical Trial 2023: AuryzoN Family of Devices Highlights & Side Effects. Trial Name: NCT03624608 — N/A

AuryzoN Family of Devices (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03624608 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the total sample size for this research study?

"Affirmative, according to the information on clinicaltrials.gov this medical study is still seeking suitable enrollees. It was first posted on March 1st 2020 and has been updated most recently on February 1st 2020. The trial requires a total of 100 volunteers across one site for completion."

Answered by AI

What benefits is this trial intended to bring about?

"This clinical evaluation, running until 2023, is seeking to measure the total time taken for cartilage processing. Supplementary objectives include gauging the duration of operative time by surgeons; ascertaining patient satisfaction through subjective surveys; and assessing the overall aesthetic quality of reconstructions using AuryzoN system as judged by both medical professionals and non-specialists."

Answered by AI

Are there any remaining opportunities to join this medical experiment?

"Affirmative. According to information hosted on clinicaltrials.gov, this medical research is actively looking for participants with recruitment commencing in March 2020 and ending February 1st 2020. 100 patients need to be enrolled at one trial site."

Answered by AI

Recent research and studies

Facial Plastic Surgery & Aesthetic MedicineJournal

Design of a Novel Reproducible Cartilage-sparing Autologous Technique for Microtia Repair

Leto Barone, Angelo A., Anirudh Arun, Georges J. Samaha, Christopher C. Shallal, Richard J. Redett, and Jordan P. Steinberg. 2021. “Design of a Novel Reproducible Cartilage-sparing Autologous Technique for Microtia Repair”. Facial Plastic Surgery & Aesthetic Medicine. Mary Ann Liebert Inc. doi:10.1089/fpsam.2020.0457.

clinicaltrials.govStudy

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

2020. "Evaluation of the Auryzon Devices in the Optimization of Ear and Nose Reconstruction Procedures". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03624608.