Nasal Valve CollapseNCT07032675
Cartilage Remodeling Using Low-Temperature Radiofrequency for Nasal Airway Reconstruction
A study testing Low-temperature radio-frequency reshaping of autologous cartilage nasal and/or auricular cartilage in people with Nasal Valve Collapse and Nose Enhancement, run by Indiana University at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nasal Valve Collapse, Nose Enhancement
- What is being tested?
- Low-temperature radio-frequency reshaping of autologous cartilage nasal and/or auricular cartilage
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 6 sitesUnited States
- Study dates
- 14 Oct 2025to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 18 years and older undergoing functional septorhinoplasty or cosmetic septorhinoplasty, with or without auricular cartilage harvest
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
IU Health Methodist Hospital
Indianapolis, Indiana, 46202
Mitchell Victor, MD, 4803499146, mtvictor@iu.edu
Mitchell Victor
- Recruiting
IU Health North Hospital
Indianapolis, Indiana, 46202
Mitchell Victor, 4803499146, mtvictor@iu.edu
- Recruiting
IU Health Saxony Hospital
Indianapolis, Indiana, 46202
Mitchell Victor, 4803499146, mtvictor@iu.edu
- Recruiting
IU Health University Hospital
Indianapolis, Indiana, 46202
Mitchell Victor, MD, 4803499146, mtvictor@iu.edu
- Recruiting
IU Health West Hospital
Indianapolis, Indiana, 46202
Mitchell Victor, 4803499146, mtvictor@iu.edu
- Recruiting
Riley Hospital for Children at IU Health
Indianapolis, Indiana, 46202
Mitchell Victor, 4803499146, mtvictor@iu.edu
About this study
Official title: Cartilage Remodeling Using Low-Temperature Radiofrequency for Facial 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:
- How many LTRF treatments are needed to achieve the desired shape in a given cartilage specimen
- How does an LTRF treatment quantitatively affect both length and angulation of a cartilage specimen
- How does physician satisfaction with cosmetic outcome compare to cases treated with existing septorhinoplasty techniques
- How do changes in patient reported measures of nasal obstruction (NOSE score) pre- and post-surgery compare to cases treated with existing septorhinoplasty techniques
- Does using LTRF during septorhinoplasty significantly increase total operative time
- Are rates of adverse events when using LTRF different from cases treated with existing septorhinoplasty techniques
Read more
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
- Nasal Valve Collapse, Nose Enhancement
- Being tested
- Low-temperature radio-frequency reshaping of autologous cartilage nasal and/or auricular cartilage
- Keywords
- low-temperature radio-frequency, nasal valve collapse, septorhinoplasty, septoplasty, rhinoplasty, cartilage reshaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-temperature radio-frequency reshaping of autologous cartilage nasal and/or auricular cartilageDevice
The device settings will be set per the manufacturer's instructions: temperature = 60° C, power = 4 W, treatment time = 18 seconds, and cooldown = 12 seconds. For curved-to-straight (CTS) samples (natively curved cartilage to be remolded to be flat), the cartilage specimens will be placed on a blue towel on a flat surface with the transmission medium over top and treated. For straight-to-curved (STC) samples (natively flat cartilage to be remolded to be curved), cartilage specimens will be placed along the inner surface of various shallow, plastic, cylindrical objects with the transmission medium over top and treated. Various device settings may be tested for reshaping efficacy.
| Study group | Role | What they receive |
|---|---|---|
| Low-temperature radio-frequency reshaping intervention | Experimental | All enrolled subjects will receive the intervention outlined in the section titled "Study Design". Receives: Device: Low-temperature radio-frequency reshaping of autologous cartilage nasal and/or auricular cartilage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of treatments needed to reach desired shape
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.
Measured: Immediately pre and post intervention (intraoperative)
Secondary outcomes (4)
Change in specimen curvature
The angle of curvature of each specimen will be measured as the angle of the intersection between two lines drawn along the distal edges of the specimen. The difference in angle of curvature before and after low-temperature radiofrequency treatment will be calculated.
Measured: Immediately pre and post intervention (intraoperative)
Change in specimen length
The apparent length of each specimen before and after treatment will be measured as a straight line between the distal points of the cartilage sample. . The differences in length before and after low-temperature radiofrequency treatment will be calculated.
Measured: Immediately pre and post intervention (intraoperative)
Nasal Obstruction Symptom Evaluation (NOSE) score
Nasal Obstruction Symptom Evaluation (NOSE) score, a validated patient-reported outcome measure of nasal airway obstruction, will be obtained at the first pre-operative visit and at the second post-operative visit (approximately 1 month after surgery). Nasal obstruction severity classification: mild (5-25) moderate (30-50) severe (55-75) extreme (80-100).
Measured: Baseline and one month
Physician satisfaction with cosmetic outcome
Preoperative and postoperative standard septorhinoplasty photographs will be compared and rated by the surgeon. In cosmetic rhinoplasty, it is standard practice to take full-face patient photographs before and after surgery to assess cosmetic outcomes (frontal, lateral, oblique, nasal base angles). Full face photographs are necessary to include all soft tissue and bony landmarks to assess nasal proportions relative to the face. They will be stored in the Vectra imaging suite software used for facial plastic surgery photography, which is currently in use clinically and is HIPPA-compliant.
Measured: Baseline and one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start14 Oct 2025
- Primary completion1 Jun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasal Valve CollapseStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Taha Shipchandler, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07032675
- Sponsor's protocol ID
- 24964
- Status last verified
- Nov 2025
- First submitted
- 16 Jun 2025
- Last updated
- 1 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cartilage Remodeling Using Low-Temperature Radiofrequency for Facial Reconstruction
- ClinicalTrials.gov ID
- NCT07032675
- Acronym / sponsor ID
- 24964
- Conditions
- Nasal Valve Collapse, Nose Enhancement
- Keywords
- low-temperature radio-frequency, nasal valve collapse, septorhinoplasty, septoplasty, rhinoplasty, cartilage reshaping
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 14 Oct 2025 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 24 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- How many LTRF treatments are needed to achieve the desired shape in a given cartilage specimen
- How does an LTRF treatment quantitatively affect both length and angulation of a cartilage specimen
- How does physician satisfaction with cosmetic outcome compare to cases treated with existing septorhinoplasty techniques
- How do changes in patient reported measures of nasal obstruction (NOSE score) pre- and post-surgery compare to cases treated with existing septorhinoplasty techniques
- Does using LTRF during septorhinoplasty significantly increase total operative time
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Low-temperature radio-frequency reshaping intervention | Experimental | Device: Low-temperature radio-frequency reshaping of autologous cartilage nasal and/or auricular cartilageAll enrolled subjects will receive the intervention outlined in the section titled "Study Design". |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients 18 years and older undergoing functional septorhinoplasty or cosmetic septorhinoplasty, with or without auricular cartilage harvest
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-temperature radio-frequency reshaping of autologous cartilage nasal and/or auricular cartilageThe device settings will be set per the manufacturer's instructions: temperature = 60° C, power = 4 W, treatment time = 18 seconds, and cooldown = 12 seconds. For curved-to-straight (CTS) samples (natively curved cartilage to be remolded to be flat), the cartilage specimens will be placed on a blue towel on a flat surface with the transmission medium over top and treated. For straight-to-curved (STC) samples (natively flat cartilage to be remolded to be curved), cartilage specimens will be placed along the inner surface of various shallow, plastic, cylindrical objects with the transmission medium over top and treated. Various device settings may be tested for reshaping efficacy. | Device | Low-temperature radio-frequency reshaping intervention |
Primary outcome
Number of treatments needed to reach desired shape
Time frame: Immediately 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.
4 secondary outcomes
Change in specimen curvature
Time frame: Immediately pre and post intervention (intraoperative)
Change in specimen length
Time frame: Immediately pre and post intervention (intraoperative)
Nasal Obstruction Symptom Evaluation (NOSE) score
Time frame: Baseline and one month
Physician satisfaction with cosmetic outcome
Time frame: Baseline and one month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-temperature radio-frequency reshaping of autologous cartilage nasal and/or auricular cartilage in people with Nasal Valve Collapse and Nose Enhancement, run by Indiana University at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mitchell Victor, MD (4803499146, mtvictor@iu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of treatments needed to reach desired shape (time frame: Immediately pre and post intervention (intraoperative)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2025.