This trial studies an outpatient procedure (VivAer) that uses radiofrequency heating to gently reshape the tissues in the nose to improve airflow and reduce refractory nasal obstruction.
- Airway Blockage
- Somatic Symptoms Disorder
- Medically Unexplained Symptoms
- Medically Unexplained Symptoms (MUS)
- Somatic Symptom Disorder
- Nasal Congestion
- Airway Remodeling
1 Primary · 2 Secondary · Reporting Duration: This will be administered before the VivAer procedure and at 4, 12, and 24 weeks post procedure.
Awards & Highlights
1 Treatment Group
1 of 1
25 Total Participants · 1 Treatment Group
Primary Treatment: VivAer Patients · No Placebo Group · N/A
Who is running the clinical trial?
Age 18+ · All Participants · 1 Total Inclusion CriteriaMark “Yes” if the following statements are true for you:
- Jacobowitz O, Driver M, Ephrat M. In-office treatment of nasal valve obstruction using a novel, bipolar radiofrequency device. Laryngoscope Investig Otolaryngol. 2019 Feb 4;4(2):211-217. doi: 10.1002/lio2.247. eCollection 2019 Apr.
- Ephrat M, Jacobowitz O, Driver M. Quality-of-life impact after in-office treatment of nasal valve obstruction with a radiofrequency device: 2-year results from a multicenter, prospective clinical trial. Int Forum Allergy Rhinol. 2021 Apr;11(4):755-765. doi: 10.1002/alr.22667. Epub 2020 Aug 9.
- Stewart, M. 2004. “Outcomes After Nasal Septoplasty: Results from the Nasal Obstruction Septoplasty Effectiveness (NOSE) Study”. Otolaryngology - Head and Neck Surgery. SAGE Publications. doi:10.1016/j.otohns.2003.12.004.
- Lipan MJ, Most SP. Development of a severity classification system for subjective nasal obstruction. JAMA Facial Plast Surg. 2013 Sep-Oct;15(5):358-61. doi: 10.1001/jamafacial.2013.344.
- Stewart MG, Smith TL, Weaver EM, Witsell DL, Yueh B, Hannley MT, Johnson JT. Outcomes after nasal septoplasty: results from the Nasal Obstruction Septoplasty Effectiveness (NOSE) study. Otolaryngol Head Neck Surg. 2004 Mar;130(3):283-90. doi: 10.1016/j.otohns.2003.12.004.
- Auddie Sweis 2022. "VivAer: A Correlation Between Symptom Scores and Objective Findings". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05573919.
Frequently Asked Questions
Are there any opportunities to join this research endeavor?
"Affirmative. Clinicaltrials.gov presents evidence that this trial is actively enrolling participants, with the initial posting date of October 7th 2022 and most recent update on December 4th 2022. This clinical trial requires 25 patients between two medical facilities." - Anonymous Online Contributor
How many individuals have volunteered to take part in this scientific experiment?
"Affirmative. Clinicaltrials.gov contains evidence that this clinical trial, initially published on October 7th 2022, is seeking participants. The total number of desired enrollees is 25 and they need to come from two distinct sites." - Anonymous Online Contributor