Cartilage Remodeling Using Low-Temperature Radiofrequency for Nasal Airway Reconstruction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Low-temperature radio-frequency reshaping of autologous cartilage nasal and/or auricular cartilage.
- Who it may be relevant to
- Registry conditions: Nasal Valve Collapse, Nose Enhancement. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Cartilage Remodeling Using Low-Temperature Radiofrequency for Facial Reconstruction
Overview
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.
Interventions
- 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 place
Primary outcome measures
- Number of treatments needed to reach desired shape [Time frame: Immediately pre and post intervention (intraoperative)]
Secondary outcome measures (4)
- Change in specimen curvature [Time frame: Immediately pre and post intervention (intraoperative)]
- Change in specimen length [Time frame: Immediately pre and post intervention (intraoperative)]
- Nasal Obstruction Symptom Evaluation (NOSE) score [Time frame: Baseline and one month]
- Physician satisfaction with cosmetic outcome [Time frame: Baseline and one month]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 6 centers
- IU Health Methodist Hospital — Indianapolis
- IU Health North Hospital — Indianapolis
- IU Health Saxony Hospital — Indianapolis
- IU Health University Hospital — Indianapolis
- IU Health West Hospital — Indianapolis
- Riley Hospital for Children at IU Health — Indianapolis
Identifiers
NCT: NCT07032675 · 24964