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NCT Number: NCT07032675

Cartilage Remodeling Using Low-Temperature Radiofrequency for Nasal Airway Reconstruction

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.

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Key information

Conditions

Nasal Valve Collapse Nose Enhancement

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IU Health Methodist Hospital, Indianapolis, Indiana, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Device

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 outcomes

  1. Number of treatments needed to reach desired shape

    Time frame: 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 outcomes

  1. Change in specimen curvature

    Time frame: 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.

  2. Change in specimen length

    Time frame: 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.

  3. Nasal Obstruction Symptom Evaluation (NOSE) score

    Time frame: 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).

  4. Physician satisfaction with cosmetic outcome

    Time frame: 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.

Other outcomes

  1. Reimplantation of LTRF-shaped specimens

    Time frame: Immediately pre and post intervention (intraoperative)

    Binary documentation of whether or not LTRF-shaped specimens are ultimately reimplanted.

  2. Time spent using low-temperature radiofrequency device

    Time frame: Immediately pre and post intervention (intraoperative)

    Time spent (minutes) using LTRF device will be recorded to quantify addition of operative time.

Study contacts

Contact information is provided by the study sponsor or research team.

Mitchell Victor, MD

CONTACT

[email protected]

4803499146

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Official study title

Cartilage Remodeling Using Low-Temperature Radiofrequency for Facial Reconstruction

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 24, 2025
Registry last updated
Dec 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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