Low-temperature radiofrequency reshaping of cartilage for nose reconstruction
Official title: Cartilage Remodeling Using Low-Temperature Radiofrequency for Facial Reconstruction
Run by Indiana University · NCT07032675 · Data updated 2026-11-12
This study will test whether a Vivaer low‑temperature radiofrequency device can reshape a patient's own nasal or ear cartilage to help with cosmetic or functional septorhinoplasty.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Indiana University Academic / other |
| Drugs / interventions | radiation |
| Locations | 6 sites (Indianapolis, Indiana and 5 other locations) |
| Status | Recruiting |
| Started | October 14, 2025 |
| Main results expected | June 1, 2027 |
| Study ends | June 2027 |
| Registry record updated | December 1, 2025 |
| Trial ID | NCT07032675 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 or older planning cosmetic or functional septorhinoplasty (with or without auricular cartilage harvest) who have not had prior septorhinoplasty, have no prior head or neck radiation or septal perforation, and are medically cleared for surgery.
✕Probably not a fit
Patients with a previous septorhinoplasty, prior head or neck radiation, a septal perforation, or who are medically ineligible for septorhinoplasty are excluded and unlikely to benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study uses the Vivaer low‑temperature radiofrequency (LTRF) device to reshape autologous nasal or auricular cartilage harvested during septorhinoplasty. Investigators will treat ex‑vivo cartilage specimens, record how many LTRF applications are needed, and measure quantitative changes in length and angulation. They will compare physician cosmetic satisfaction and patient‑reported nasal obstruction (NOSE) scores to cases managed with standard septorhinoplasty techniques, track total operative time, and monitor adverse events. Procedures and follow‑up will occur at Indiana University Health hospitals in Indianapolis.
Why it matters
Potential benefit: If successful, this technique could let surgeons reshape cartilage more predictably during septorhinoplasty, potentially improving cosmetic and breathing outcomes and reducing operative time.
How similar studies have gone: Low‑temperature radiofrequency is used for intranasal soft‑tissue remodeling, but using LTRF for ex‑vivo cartilage reshaping in septorhinoplasty is relatively novel with limited prior clinical data.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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IU Health Methodist Hospital
Indianapolis, Indiana, United States Recruiting -
IU Health North Hospital
Indianapolis, Indiana, United States Recruiting -
IU Health Saxony Hospital
Indianapolis, Indiana, United States Recruiting -
IU Health University Hospital
Indianapolis, Indiana, United States Recruiting -
IU Health West Hospital
Indianapolis, Indiana, United States Recruiting -
Riley Hospital for Children at IU Health
Indianapolis, Indiana, United States Recruiting
Study contacts
- Study coordinator: Mitchell Victor, MD
- Email: mtvictor@iu.edu
- Phone: 4803499146
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.