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Cartilage Remodeling Using Low-Temperature Radiofrequency for Nasal Airway Reconstruction
NCT07032675 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DEVICE Low-temperature radio-frequency reshaping of autologous cartilage nasal and/or auricular cartilage
Study Locations (6)
Indiana
- 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
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2025-10-14 |
| Est. Completion | 2027-06 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07032675
The ClinicalTrials.gov registry entry for NCT07032675 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Indiana University, which has 1,026 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Nasal Valve Collapse appearing as the primary indexed condition, and to 1 intervention — of which Low-temperature radio-frequency reshaping of autologous cartilage nasal and/or auricular cartilage is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07032675 reports 6 study locations spanning 1 distinct geographic area — top geographies include Indiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT07032675 about?
NCT07032675 is a clinical study titled "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 ...
What is the current status of trial NCT07032675?
This trial is currently recruiting. It is a NA study. The enrollment target is 20 participants. The study started on 2025-10-14. Estimated completion is 2027-06.
What conditions does trial NCT07032675 study?
This clinical trial studies the following conditions: Nasal Valve Collapse, Nose Enhancement. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07032675?
The interventions under investigation include: Low-temperature radio-frequency reshaping of autologous cartilage nasal and/or auricular cartilage (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07032675?
This trial is sponsored by Indiana University, which has 1,026 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT07032675 being conducted?
This trial has 6 study locations across Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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