Cartilage Remodeling Using Low-Temperature Radiofrequency for Nasal Airway Reconstruction

Indiana University

Status: Enrolling

Conditions: Nose Enhancement; Nasal Valve Collapse

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07032675

24964

Details and patient eligibility

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Low-temperature radio-frequency reshaping intervention

Experimental group

Description:

All enrolled subjects will receive the intervention outlined in the section titled "Study Design".

Treatment:

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