Condition: Nasal Valve Collapse · Nose Enhancement · Sponsor: Indiana University
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 using LTRF different from cases treated with existing septorhinoplasty techniques Participants will complete the NOSE questionnaire at their pre-operative visit. Participants undergoing cosmetic septhorhinoplasty will also be photographed in standard fashion for facial analysis. During scheduled septorhinoplasty surgery, the Vivaer LTRF device will be used to reshape nasal and/or auricular cartilage ex-vivo prior to reimplantation at the discretion of the Principal Investigator in order to optimize functional and cosmetic outcome. Participants will follow up at approximately 1 week and 1 m…
This description comes directly from the study's public registry record.
Mitchell Victor, MD · 4803499146 · mtvictor@iu.edu
Always discuss trial participation with your own doctor first.
| IU Health Methodist Hospital | Indianapolis, Indiana, United States | Recruiting |
| IU Health North Hospital | Indianapolis, Indiana, United States | Recruiting |
| IU Health Saxony Hospital | Indianapolis, Indiana, United States | Recruiting |
| IU Health University Hospital | Indianapolis, Indiana, United States | Recruiting |
| IU Health West Hospital | Indianapolis, Indiana, United States | Recruiting |
| Riley Hospital for Children at IU Health | Indianapolis, Indiana, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07032675