What is this study studying for nasal valve collapse and nose enhancement?

This study is evaluating how the Vivaer low-temperature radio-frequency device can reshape nasal and ear cartilage during septorhinoplasty surgery. Researchers want to understand how many treatments are needed, the changes in cartilage shape, and how outcomes compare to current surgical techniques. Indiana University is leading this research to improve cosmetic and functional nasal surgery.

Who may be eligible for this nasal valve collapse and nose enhancement clinical trial?

Adults 18 years and older undergoing functional or cosmetic septorhinoplasty may be eligible. The study includes patients with or without ear cartilage harvest and excludes those with prior septorhinoplasty, previous head or neck radiation, septal perforation, or medical ineligibility for surgery. Please review eligibility criteria for more details.

Is there any cost to participate in this nasal valve collapse and nose enhancement clinical trial?

Study-related care, including the use of the Vivaer device and all trial visits, is provided at no cost. However, personal travel expenses and other costs are not guaranteed to be covered and may vary by participant.

Actively Recruiting

Phase Not Applicable

Age: 18Years +

All Genders

ID07032675

Cartilage Remodeling Using Low-Temperature Radiofrequency for Facial Reconstruction

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

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the use of the Vivaer low-temperature radio-frequency (LTRF) device to reshape human nasal or ear cartilage outside the body for cosmetic and functional septorhinoplasty. The study aims to determine the number of LTRF treatments needed to achieve the desired cartilage shape, measure changes in cartilage length and angle, compare physician satisfaction with cosmetic results to traditional techniques, assess changes in nasal obstruction symptoms, evaluate if LTRF increases surgery time, and observe rates of adverse events compared to current methods. Participants will undergo septorhinoplasty surgery where the Vivaer LTRF device will be applied ex-vivo to reshape nasal or auricular cartilage before reimplantation. The device operates at 60°C, 4 watts, with treatments lasting 18 seconds plus 12 seconds cooldown, using specific positioning depending on whether the cartilage is being straightened or curved. Various device settings may be tested to optimize reshaping effectiveness. All participants receive this intervention as part of the study. Participants complete a nasal obstruction symptom questionnaire (NOSE score) before surgery and again one month after. Cosmetic patients are also photographed for facial analysis before and one month after surgery. Follow-up visits occur around one week and one month post-surgery to assess outcomes including cartilage shape changes during surgery, nasal obstruction symptoms, cosmetic satisfaction, and any adverse events. The study is sponsored by Indiana University and runs from October 2025 to June 2027.

CONDITIONS

Brief Title

Cartilage Remodeling Using Low-Temperature Radiofrequency for Nasal Airway Reconstruction

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

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

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - Single procedure

Participants receive low-temperature radio-frequency reshaping of their autologous nasal and/or auricular cartilage during septorhinoplasty surgery.

1 intraoperative visit

Post-operative Follow-up

Duration - 1 month

Participants are monitored for outcomes including nasal obstruction symptoms and physician satisfaction with cosmetic results.

1 follow-up visit approximately 1 month after surgery