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โ† Trials
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Cartilage Remodeling Using Low-Temperature Radiofrequency for Nasal Airway Reconstruction

RecruitingNAAges 18 Years - anyAllIndiana University
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In plain words

What the trial is, and whether it could suit you

The goal of this study is to evaluate the efficacy of using the Vivaer low-temperature radio-frequency (LTRF) device to reshape ex-vivo human nasal or auricular cartilage for use in cosmetic and functional septorhinoplasty. The investigators hope to answer the following questions: 1. How many LTRF treatments are needed to achieve the desired shape in a given cartilage specimen 2. How does an LTRF treatment quantitatively affect both length and angulation of a cartilage specimen 3. How does physician satisfaction with cosmetic outcome compare to cases treated with existing septorhinoplasty techniques 4. How do changes in patient reported measures of nasal obstruction (NOSE score) pre- and post-surgery compare to cases treated with existing septorhinoplasty techniques 5. Does using LTRF during septorhinoplasty significantly increase total operative time 6. Are rates of adverse events when

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: โ€ข Patients 18 years and older undergoing functional septorhinoplasty or cosmetic septorhinoplasty, with or without auricular cartilage harvest Exclusion Criteria: * Patients who have had a prior septorhinoplasty * Patients who have received prior head and neck radiation * Patients with a septal perforation * Patients who are medically ineligible to undergo septorhinoplasty.
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What it tests

  • Low-temperature radio-frequency reshaping of autologous cartilage nasal and/or auricular cartilage
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Where

6 sites
IU Health Methodist Hospital
Indianapolis, United States
IU Health North Hospital
Indianapolis, United States
IU Health Saxony Hospital
Indianapolis, United States
IU Health University Hospital
Indianapolis, United States
IU Health West Hospital
Indianapolis, United States
Riley Hospital for Children at IU Health
Indianapolis, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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