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NCT07032675 · ClinicalTrials.gov registry record · NA
Cartilage Remodeling Using Low-Temperature Radiofrequency for Nasal Airway Reconstruction
A NA study of Nasal Valve Collapse and Nose Enhancement, sponsored by Indiana University.
- Recruiting
- Registry status
- NA
- Development phase
- 20
- Enrollment target
- 6
- Study locations
NCT07032675 is a NA study of Nasal Valve Collapse and Nose Enhancement that is actively recruiting participants, run by Indiana University. The registered enrollment target is 20 participants. The trial reports 6 study locations across 1 state.
The verdict
NCT07032675, a NA study of Nasal Valve Collapse and Nose Enhancement, is actively recruiting participants, sponsored by Indiana University.
- RECRUITING
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
- 6
- Study locations
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 |
Interested in This Trial?
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, categorized as NA. 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 890 total studies on file at ClinicalTrials.gov.
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.
NCT07032675 reports 6 study locations spanning 1 distinct geographic area - top geographies include Indiana.
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.
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).
Who is sponsoring clinical trial NCT07032675?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
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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