Recruiting

Vivaer LTRF

Sponsor:

Indiana University

Code:

NCT07032675

Conditions

Nasal Valve Collapse

Nose Enhancement

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

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.

Conditions

Nasal Valve Collapse

Nose Enhancement

Study ID

NCT07032675

Start date

Oct 14, 2025

Status verified date

Nov, 2025

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Low-temperature radio-frequency reshaping intervention

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

Interventions

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.

Primary outcome measure

  • Number of treatments needed to reach desired shape [ Time Frame: Immediately pre and post intervention (intraoperative) ]

Central Contacts and Locations

Central contacts

Mitchell Victor, MD

4803499146mtvictor@iu.edu

Locations

IU Health Methodist Hospital

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Mitchell Victor, MD

4803499146mtvictor@iu.edu

IU Health North Hospital

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

IU Health Saxony Hospital

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

IU Health University Hospital

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Mitchell Victor, MD

4803499146mtvictor@iu.edu

IU Health West Hospital

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Riley Hospital for Children at IU Health

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

More Information

Sponsor

Indiana University

Last update posted

Dec 1, 2025

Last verified

Nov, 2025

Keywords

  • low-temperature radio-frequency
  • nasal valve collapse
  • septorhinoplasty
  • septoplasty
  • rhinoplasty
  • cartilage reshaping

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Indiana University on 2025-12-01.