Low-temperature radiofrequency reshaping of cartilage for nose reconstruction
Cartilage Remodeling Using Low-Temperature Radiofrequency for Facial Reconstruction
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Indiana University Academic / other |
| Drugs / interventions | radiation |
| Locations | 6 sites (Indianapolis, Indiana and 5 other locations) |
| Trial ID | NCT07032675 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Indianapolis, Indiana and 5 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.