Cartilage Remodeling for Nasal Airway Reconstruction

This study is looking at a new way to reshape cartilage using a device called Vivaer low-temperature radio-frequency (LTRF). This device uses heat to change the shape of cartilage taken from your nose or ear. The goal is to see how many treatments are needed to get the desired shape and how it affects the cartilage. Researchers also want to compare how happy doctors are with the cosmetic results and how patients' breathing improves compared to current surgical methods. You might be able to join if you are 18 or older and are having nose surgery (septorhinoplasty) for function or appearance. You cannot join if you've had nose surgery before, head and neck radiation, or a hole in your septum. This study is currently unclear about its recruitment status and plans to enroll 20 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 20 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, the number of treatments needed, is measured immediately before and after the intervention (intraoperative).

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NCT07032675

Cartilage Remodeling Using Low-Temperature Radiofrequency for Nasal Airway Reconstruction

Recruiting
NAAges 18+InterventionalTreatment
Indiana University
~20 participants
Updated 2025-12-01 on ClinicalTrials.gov
What's tested:Low-temperature radio-frequency reshaping of autologous cartilage nasal and/or auricular cartilage

At a glance

Recruiting sites
6 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of treatments needed to reach desired shape
Measured over Immediately pre and post intervention (intraoperative)
Nasal Valve Collapse
Nose Enhancement
6 sites across 1 states
Indiana6

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Eligibility criteria

Exclusion

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.
  • Number of treatments needed to reach desired shapeImmediately 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.