Cartilage Remodeling Using Low-Temperature Radiofrequency for Nasal Airway Reconstruction

Recruiting now · Not applicable

Conditions studied: Nasal Valve Collapse, Nose Enhancement

In brief

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.

Key facts

Study ID

NCT07032675

Run by

Indiana University

People needed

20

Starts

2025-10-14

Expected to finish

2027-06-01

Last updated by the study team

2025-12-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients 18 years and older undergoing functional septorhinoplasty or cosmetic septorhinoplasty, with or without auricular cartilage harvest

You may not qualify if…

• 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.

Where it is running

• IU Health Methodist Hospital — Indianapolis, Indiana, United States (enrolling)
• IU Health North Hospital — Indianapolis, Indiana, United States (enrolling)
• IU Health Saxony Hospital — Indianapolis, Indiana, United States (enrolling)
• IU Health University Hospital — Indianapolis, Indiana, United States (enrolling)
• IU Health West Hospital — Indianapolis, Indiana, United States (enrolling)
• Riley Hospital for Children at IU Health — Indianapolis, Indiana, United States (enrolling)

Full record on ClinicalTrials.gov

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