NCT07032675

Cartilage Remodeling Using Low-Temperature Radiofrequency for Nasal Airway Reconstruction

Cartilage Remodeling Using Low-Temperature Radiofrequency for Facial Reconstruction

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Nasal Valve Collapse
• Nose Enhancement

Interventions

Type	Name	Description
DEVICE	Low-temperature radio-frequency reshaping of autologous cartilage nasal and/or auricular cartilage	The device settings will be set per the manufacturer's instructions: temperature = 60° C, power = 4 W, treatment time = 18 seconds, and cooldown = 12 seconds. For curved-to-straight (CTS) samples (natively curved cartilage to be remolded to be flat), the cartilage specimens will be placed on a blue towel on a flat surface with the transmission medium over top and treated. For straight-to-curved (STC) samples (natively flat cartilage to be remolded to be curved), cartilage specimens will be placed along the inner surface of various shallow, plastic, cylindrical objects with the transmission medium over top and treated. Various device settings may be tested for reshaping efficacy.

Timeline

• Start date: 2025-10-14
• Primary completion: 2027-06-01
• Completion: 2027-06-01
• First posted: 2025-06-24
• Last updated: 2025-12-01

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated device study