Vivaer® Procedure for Treatment of Nasal Airway Obstruction Study
NCT ID: NCT04549545
Last Updated: 2025-08-28
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
119 participants
INTERVENTIONAL
2020-08-12
2025-03-04
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evaluate the Effectiveness of the Vivaer ARC Stylus for Nasal Breathing
NCT04717791
A Prospective Study Comparing VivAer to Alternative Surgical Procedures to Treat Nasal Airway Obstruction in Patients With Nasal Valve Dysfunction.
NCT06922955
Treatment of Nasal Airway Obstruction Using the Aerin Medical Device
NCT02914236
RhinAer Procedure for Treatment of Chronic Rhinitis Study
NCT04533438
VivAer: A Correlation Between Symptom Scores and Objective Findings
NCT05573919
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Vivaer Procedure
The Vivaer procedure will be performed in the study clinic using the Vivaer ARC Stylus and Aerin Console. The Vivaer ARC Stylus is a disposable handheld device capable of delivering bipolar radiofrequency energy to tissue when connected to the Aerin Console radiofrequency generating device. Participants in this study will undergo bilateral treatment of the nasal valves in a single study session. Each side of the nose will be treated with up to four (4) non-overlapping applications of RF energy at the junction of the upper and lower lateral cartilage on the lateral nasal wall. Treatment settings to be used are: temperature 60° C, power 4 watts, treatment time 18 seconds, and cooling time 12 seconds. No repeat ("touch up") procedures will be permitted after the initial procedure through the end of the study (24 months).
Vivaer ARC Stylus
The Vivaer procedure will be performed in the study clinic using the Vivaer ARC Stylus and Aerin Console. The Vivaer ARC Stylus is a disposable handheld device capable of delivering bipolar radiofrequency energy to tissue when connected to the Aerin Console radiofrequency generating device. Participants in this study will undergo bilateral treatment of the nasal valves in a single study session.
Sham Control Procedure
The sham control procedure will be performed in the study clinic using the Vivaer ARC Stylus while audible sounds that accurately simulate the Aerin Console's active treatment are produced even though RF energy is not being generated or delivered. All other aspects of the procedure will be the same as used for the active treatment, including administration of anesthetic agent(s).
Sham
The sham control procedure will be performed in the study clinic using the Vivaer ARC Stylus while audible sounds that accurately simulate the Aerin Console's active treatment are produced even though RF energy is not being generated or delivered. All other aspects of the procedure will be the same as used for the active treatment, including administration of anesthetic agent(s).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Vivaer ARC Stylus
The Vivaer procedure will be performed in the study clinic using the Vivaer ARC Stylus and Aerin Console. The Vivaer ARC Stylus is a disposable handheld device capable of delivering bipolar radiofrequency energy to tissue when connected to the Aerin Console radiofrequency generating device. Participants in this study will undergo bilateral treatment of the nasal valves in a single study session.
Sham
The sham control procedure will be performed in the study clinic using the Vivaer ARC Stylus while audible sounds that accurately simulate the Aerin Console's active treatment are produced even though RF energy is not being generated or delivered. All other aspects of the procedure will be the same as used for the active treatment, including administration of anesthetic agent(s).
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Willing and able to provide informed consent.
3. Willing and able to comply with the subject-specific requirements outlined in the Study Protocol.
4. Seeking treatment for nasal obstruction and willing to undergo an office-based procedure.
5. Baseline Nasal Obstruction Symptom Evaluation (NOSE) Scale score ≥ 55.
6. Nasal valve is a primary or significant contributor to the patient's nasal obstruction as determined by the study investigator (based on clinical presentation, physical examination, nasal endoscopy, etc.) and the patient has a positive response to any of the following temporary measures (based on patient history or office exam):
* Use of external nasal dilator strips (eg, Breathe Right Strips)
* Use of internal nasal dilator cones
* Modified Cottle Maneuver (manual elevation of the lateral nasal wall using a small instrument or cotton-tipped applicator to open the nasal valve)
* Cottle Maneuver (manual lateral retraction of the cheek to open the nasal valve)
7. Dissatisfaction with medical management as judged by the patient. Defined as failed medical therapy (eg, decongestants, antihistamines, and/or nasal sprays for an appropriate period of time), but a positive response to internal or external nasal dilators.
Exclusion Criteria
2. Rhinoplasty, septoplasty, inferior turbinate reduction or functional endoscopic sinus surgery (FESS) within the preceding 3 months.
3. Severe case of any of the following: septal deviation, turbinate hypertrophy, polyps, or ptotic nose tip believed to be the primary contributor to the patient's nasal obstruction symptoms and warranting surgical intervention.
4. Any adjunctive surgical nasal procedure planned on the same day or within 6 months after the Vivaer procedure.
5. Known or suspected to be pregnant or is lactating.
6. Participating in another clinical research study.
7. Other medical conditions which in the opinion of the investigator would predispose the patient to poor wound healing or increased surgical risk, or poor compliance with the requirements of the study.
18 Years
85 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Aerin Medical
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Joseph Han, MD
Role: PRINCIPAL_INVESTIGATOR
EVMS Medical Group
Stacey Silvers, MD
Role: PRINCIPAL_INVESTIGATOR
Madison ENT
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Roseville Facial Plastic Surgery
Roseville, California, United States
Breathe Clear Institute
Torrance, California, United States
ENT and Allergy Associates of Florida
Coral Springs, Florida, United States
ENT Associates of South Florida
Fort Lauderdale, Florida, United States
ENT and Allergy Associates of Florida
Port Saint Lucie, Florida, United States
Advanced ENT and Allergy KY
Louisville, Kentucky, United States
Madison ENT
New York, New York, United States
Piedmont ENT Associates NC
Winston-Salem, North Carolina, United States
Bethlehem ENT
Bethlehem, Pennsylvania, United States
ENT Associates of Texas (ENTtex)
McKinney, Texas, United States
Ogden Clinic
Ogden, Utah, United States
EVMS Ear Nose and Throat Surgeons
Norfolk, Virginia, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Silvers SL, Rosenthal JN, McDuffie CM, Yen DM, Han JK. Temperature-controlled radiofrequency device treatment of the nasal valve for nasal airway obstruction: A randomized controlled trial. Int Forum Allergy Rhinol. 2021 Dec;11(12):1676-1684. doi: 10.1002/alr.22861. Epub 2021 Jul 9.
Han JK, Silvers SL, Rosenthal JN, McDuffie CM, Yen DM. Outcomes 12 Months After Temperature-Controlled Radiofrequency Device Treatment of the Nasal Valve for Patients With Nasal Airway Obstruction. JAMA Otolaryngol Head Neck Surg. 2022 Oct 1;148(10):940-946. doi: 10.1001/jamaoto.2022.2293.
Silvers SL, McDuffie CM, Yen DM, Rosenthal JN, Davis SE, Han JK. Two-year outcomes of radiofrequency device treatment of the nasal valve for nasal airway obstruction. Rhinology. 2024 Jun 1;62(3):310-319. doi: 10.4193/RhinRhin23.377.
Han JK, Rosenthal JN, McDuffie CM, Yen DM, Bikhazi NB, Kakarlapudi VV, Silvers SL. Temperature-Controlled Radiofrequency Treatment of the Nasal Valve in Patients With Nasal Obstruction: Long-Term Outcomes. Otolaryngol Head Neck Surg. 2025 Apr;172(4):1214-1223. doi: 10.1002/ohn.1118. Epub 2025 Jan 17.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CTP1006
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.