Cartilage Remodeling Using Low-Temperature Radiofrequency for Nasal Airway Reconstruction

Not Applicable

Not yet recruiting

• Conditions: Nasal Valve Collapse; Nose Enhancement

• Registration Number: NCT07032675
• Lead Sponsor: Indiana University

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-16
• Study First Submitted QC: 2025-06-16
• Study First Posted: 2025-06-24
• Last Update Submitted: 2025-06-24
• Last Update Posted: 2025-06-27
• Study Start: 2025-08-01
• Primary Completion: 2027-06-01
• Study Completion: 2027-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of treatments needed to reach desired shape	Immediately pre and post intervention (intraoperative)	The primary outcome measure will be the efficacy of reshaping cartilage from straight to curved and from curved to straight for use in septorhinoplasty. The number of treatments needed to create the desired shapes and curvatures will be measured for each cartilage specimen.

Secondary Outcome Measures

Name	Time	Method
Change in specimen curvature	Immediately pre and post intervention (intraoperative)	The angle of curvature of each specimen will be measured as the angle of the intersection between two lines drawn along the distal edges of the specimen. The difference in angle of curvature before and after low-temperature radiofrequency treatment will be calculated.
Change in specimen length	Immediately pre and post intervention (intraoperative)	The apparent length of each specimen before and after treatment will be measured as a straight line between the distal points of the cartilage sample. . The differences in length before and after low-temperature radiofrequency treatment will be calculated.
Nasal Obstruction Symptom Evaluation (NOSE) score	Baseline and one month	Nasal Obstruction Symptom Evaluation (NOSE) score, a validated patient-reported outcome measure of nasal airway obstruction, will be obtained at the first pre-operative visit and at the second post-operative visit (approximately 1 month after surgery). Nasal obstruction severity classification: mild (5-25) moderate (30-50) severe (55-75) extreme (80-100).
Physician satisfaction with cosmetic outcome	Baseline and one month	Preoperative and postoperative standard septorhinoplasty photographs will be compared and rated by the surgeon. In cosmetic rhinoplasty, it is standard practice to take full-face patient photographs before and after surgery to assess cosmetic outcomes (frontal, lateral, oblique, nasal base angles). Full face photographs are necessary to include all soft tissue and bony landmarks to assess nasal proportions relative to the face. They will be stored in the Vectra imaging suite software used for facial plastic surgery photography, which is currently in use clinically and is HIPPA-compliant.

Trial Locations

Locations (6)

IU Health Methodist Hospital; 🇺🇸 Indianapolis, Indiana, United States

IU Health North Hospital; 🇺🇸 Indianapolis, Indiana, United States

IU Health Saxony Hospital; 🇺🇸 Indianapolis, Indiana, United States

IU Health University Hospital; 🇺🇸 Indianapolis, Indiana, United States

IU Health West Hospital; 🇺🇸 Indianapolis, Indiana, United States

Riley Hospital for Children at IU Health; 🇺🇸 Indianapolis, Indiana, United States