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NCT07032675NARecruiting

Cartilage Remodeling Using Low-Temperature Radiofrequency for Nasal Airway Reconstruction

Indiana University

Start Date

10/14/2025

Completion Date

6/1/2027

Summary

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 month after surgery. At 1 month, the NOSE questionnaire will be readministered to all participants, and cosmetic patients will be photographed again.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: • 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.

Interventions

DEVICE

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

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Conditions

Nasal Valve CollapseNose Enhancement

Locations

IU Health Methodist Hospital

Indianapolis, Indiana 46202

United States

IU Health North Hospital

Indianapolis, Indiana 46202

United States

IU Health Saxony Hospital

Indianapolis, Indiana 46202

United States

IU Health University Hospital

Indianapolis, Indiana 46202

United States

IU Health West Hospital

Indianapolis, Indiana 46202

United States

Riley Hospital for Children at IU Health

Indianapolis, Indiana 46202

United States