Clinical trial NCT04549545: Vivaer® Procedure for Treatment of Nasal Airway Obstruction Study
Official title: The Vivaer® Procedure for Treatment of Nasal Airway Obstruction - A ProspecTive, Multicenter Randomized Controlled TriAl Comparing Vivaer to Sham Control (VATRAC)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Nasal Airway Obstruction
Keywords: Nasal obstruction
NAO
Nasal valve dysfunction
Nasal airway obstruction
Lead sponsor: Aerin Medical
Sponsor class: INDUSTRY
First posted: 2020-09-16
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 2:1 site-stratified randomization will be used to allocate participants to either the active treatment arm (Vivaer procedure) or the control arm (sham procedure). Crossover within 30 days after 3 month follow-up visit.
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the Vivaer procedure with radiofrequency (RF) energy to sham procedure for treatment of nasal airway obstruction (NAO).

Detailed description: The purpose of this study is to compare the Vivaer procedure for treatment of nasal airway obstruction (NAO) with a sham procedure that simulates the actual procedure as closely as possible absent the delivery of radiofrequency (RF) energy to the nasal tissue.

Eligibility criteria: Inclusion Criteria:

1. Age 18 to 85 years (inclusively).
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:

1. Prior surgery of the lateral nasal wall, including cephalic resection of the lower lateral cartilage, dome division or suture plication, alar graft or spreader graft placement.
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.

Primary outcomes:
measure: Nasal Obstruction Symptom Evaluation (NOSE) Scale - 3 Month Responder Rate
timeFrame: 3 months visit following the study procedure.
Secondary outcomes:
measure: Nasal Obstruction Symptom Evaluation (NOSE) Scale Mean Change From Baseline Through 3 Months
timeFrame: Change from Baseline to 3 months following the study procedure.
measure: Percentage of Participants With Treatment Related Events (Safety) - Through 3 Months
timeFrame: At or following the study procedure up to to 3 months.
Other outcomes:
measure: NOSE Scale Score - 3 Month Responder Rate Improvement in NOSE Score
timeFrame: 3 Month
measure: NOSE Scale Score - 3 Month Average
timeFrame: 3 Month
measure: NOSE Scale Score - 6 Month Average
timeFrame: 6 Month
measure: NOSE Scale Score - 12 Month Average
timeFrame: 12 Month
measure: NOSE Scale Score - 24 Month Average
timeFrame: 24 Month
measure: NOSE Scale Score - 6 Month Responder Rate Improvement in NOSE Score
timeFrame: 6 Month
measure: NOSE Scale Score - 12 Month Responder Rate Improvement in NOSE Score
timeFrame: 12 Month
measure: NOSE Scale Score -24 Month Responder Rate Improvement in NOSE Score
timeFrame: 24 Month
measure: Epworth Sleepiness Scale - 3 Month
timeFrame: 3 Months
measure: Epworth Sleepiness Scale - 6 Month
timeFrame: 6 Months
measure: Epworth Sleepiness Scale - 12 Months
timeFrame: 12 Months
measure: Epworth Sleepiness Scale - 24 Months
timeFrame: 24 Months
measure: Concomitant Medication and Mechanical Nasal Aid Analysis
timeFrame: 12 Months
Locations:
city: Roseville
country: United States
facility: Roseville Facial Plastic Surgery
state: California
city: Torrance
country: United States
facility: Breathe Clear Institute
state: California
city: Coral Springs
country: United States
facility: ENT and Allergy Associates of Florida
state: Florida
city: Fort Lauderdale
country: United States
facility: ENT Associates of South Florida
state: Florida
city: Port Saint Lucie
country: United States
facility: ENT and Allergy Associates of Florida
state: Florida
city: Louisville
country: United States
facility: Advanced ENT and Allergy KY
state: Kentucky
city: New York
country: United States
facility: Madison ENT
state: New York
city: Winston-Salem
country: United States
facility: Piedmont ENT Associates NC
state: North Carolina
city: Bethlehem
country: United States
facility: Bethlehem ENT
state: Pennsylvania
city: McKinney
country: United States
facility: ENT Associates of Texas (ENTtex)
state: Texas
city: Ogden
country: United States
facility: Ogden Clinic
state: Utah
city: Norfolk
country: United States
facility: EVMS Ear Nose and Throat Surgeons
state: Virginia
Study officials:
affiliation: EVMS Medical Group
name: Joseph Han, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Madison ENT
name: Stacey Silvers, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.