Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07032675

Cartilage Remodeling Using Low-Temperature Radiofrequency for Nasal Airway Reconstruction

Led by Indiana University · Updated on 2025-12-01

20

Participants Needed

6

Research Sites

85 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Cartilage Remodeling Using Low-Temperature Radiofrequency for Nasal Airway Reconstruction

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients 18 years and older undergoing functional septorhinoplasty or cosmetic septorhinoplasty, with or without auricular cartilage harvest
Not Eligible

You will not qualify if you...

  • 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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Trial Site Locations

Total: 6 locations

1

IU Health Methodist Hospital

Indianapolis, Indiana, United States, 46202

Actively Recruiting

2

IU Health North Hospital

Indianapolis, Indiana, United States, 46202

Actively Recruiting

3

IU Health Saxony Hospital

Indianapolis, Indiana, United States, 46202

Actively Recruiting

4

IU Health University Hospital

Indianapolis, Indiana, United States, 46202

Actively Recruiting

5

IU Health West Hospital

Indianapolis, Indiana, United States, 46202

Actively Recruiting

6

Riley Hospital for Children at IU Health

Indianapolis, Indiana, United States, 46202

Actively Recruiting

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Research Team

M

Mitchell Victor, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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