Low-Temperature Radiofrequency for Nasal Valve Collapse
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new method to improve nose surgeries by using low-temperature radiofrequency (LTRF) to reshape cartilage. Researchers aim to determine if this technique enhances both the appearance and function of the nose more effectively than current methods. They are also evaluating its impact on surgery time and potential side effects. Suitable candidates include individuals planning nose surgery for breathing issues or cosmetic reasons who have not undergone previous nose surgery.
As an unphased trial, this study provides a unique opportunity to contribute to innovative surgical advancements.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that the Vivaer low-temperature radio-frequency device is safe for reshaping nasal or auricular cartilage?
Research has shown that low-temperature radiofrequency (LTRF) treatment for reshaping nasal cartilage is generally safe. Studies have found that temperature-controlled devices can improve symptoms of nasal blockage.
In one study, 91.6% of participants reported positive results after treatment, indicating it is well-tolerated. Additionally, the research available has not reported any major negative effects related to this procedure. These findings suggest that LTRF treatment is safe for reshaping nasal cartilage.12345Why are researchers excited about this trial?
Low-temperature radiofrequency reshaping is unique because it offers a minimally invasive approach to treating nasal valve collapse, which is often managed with surgical procedures or nasal dilators. This technique uses controlled radiofrequency energy at a low temperature to reshape the nasal tissue, potentially reducing recovery time and discomfort compared to traditional surgery. Researchers are excited about its potential to provide effective relief with fewer side effects and a quicker return to normal activities.
What evidence suggests that the Vivaer low-temperature radio-frequency device is effective for nasal valve collapse?
Research has shown that low-temperature radiofrequency (LTRF) treatment can alleviate symptoms of nasal valve collapse. In earlier studies, patients reported a noticeable decrease in nasal blockage. Specifically, the NOSE score, which measures nasal obstruction, improved by up to 55.6%. These benefits persisted for a long time, lasting up to 48 months in some cases. Additionally, LTRF treatment was associated with better sleep quality due to easier breathing. Overall, the evidence suggests that LTRF effectively treats nasal blockage and enhances nasal breathing.23467
Are You a Good Fit for This Trial?
This trial is for individuals undergoing septorhinoplasty to correct nasal valve collapse or for cosmetic reasons. Participants must be willing to complete questionnaires and undergo photography if needed. Specific inclusion and exclusion criteria are not provided, but typically involve being an adult candidate for the surgery with no contraindications.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-operative Assessment
Participants complete the NOSE questionnaire and are photographed for facial analysis
Treatment
During septorhinoplasty surgery, the Vivaer LTRF device is used to reshape nasal and/or auricular cartilage ex-vivo
Follow-up
Participants are monitored for safety and effectiveness; NOSE questionnaire readministered and photographs taken
What Are the Treatments Tested in This Trial?
Interventions
- Low-Temperature Radiofrequency Reshaping
Find a Clinic Near You
Who Is Running the Clinical Trial?
Indiana University
Lead Sponsor