Clinical trial NCT05099263: The Vivaer Procedure for Treatment of the Septal Swell Bodies (SWELL)
Official title: The Vivaer Procedure for Treatment of the Septal Swell Bodies for Airway Obstruction - A Prospective Open-Label Multicenter Study (SWELL)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Nasal Obstruction
Lead sponsor: Aerin Medical
Sponsor class: INDUSTRY
First posted: 2021-10-29
Enrollment: 70
Sex: ALL
Minimum age (years): 22
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Post-market study to access the clinical use of the Vivaer Arc Stylus to treat Septal Swell Bodies (SSB).

Detailed description: Prospective, Open-Label, Multicenter, Single Arm Study of the Aerin Medical Vivaer ARC Stylus to treat Septal Swell Bodies (SSB) to improve symptoms in adults diagnosed with nasal obstruction attributed to SSB.

Eligibility criteria: Inclusion Criteria:

1. Age 22 to 85 years (inclusively).
2. Seeking treatment for nasal obstruction and willing to undergo an office-based procedure.
3. Baseline NOSE score ≥ 55.
4. Presence of SSB hypertrophy limiting visualization of the middle turbinate (MT) by more than 50%.
5. Reduction in size of the SSB after application of topical decongestant on a cotton plug directly to the SSB region.
6. Improvement in the symptoms of nasal obstruction after SSB decongestion suggesting that the SSB may play a role in nasal obstruction.
7. Willing and able to withhold anticoagulant medications during the perioperative period (3-day window on either side).
8. Willing and able to provide informed consent.
9. Willing and able to comply with the participant-specific requirements outlined in the study protocol.

Exclusion Criteria:

1. Rhinoplasty, septoplasty, inferior turbinate (IT) reduction, or other surgical nasal procedures within the preceding 6 months.
2. Severe case of any of the following: septal deviation, turbinate hypertrophy, polyps, or ptotic nose tip believed to be the primary contributor to the participant's nasal obstruction symptoms and warranting surgical intervention.
3. Any adjunctive surgical nasal procedure planned on the same day or within 3 months after the Vivaer procedure.
4. Known or suspected allergies or contraindications for any general or local anesthetic agents.
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 participant to poor wound healing or increased surgical risk, or poor compliance with the requirements of the study.
8. Known or suspected regular use of oxymetazoline (Afrin) nasal decongestant or oral steroids.
9. For sites participating in the CT substudy only: Active sinus condition (eg, significant sinus diseases, infection or polyp formation) identified by CT.

Primary outcomes:
measure: Nasal Obstruction Symptom Evaluation (NOSE) Scale Mean Change
timeFrame: 3 months (13 weeks) visit following screening
Secondary outcomes:
measure: Responder Percent
timeFrame: 3 months (13 weeks) visit following baseline
measure: Number of Participants With Device Related Adverse Events
timeFrame: At or following the study procedure up to 3 months.
Other outcomes:
Locations:
city: Colorado Springs
country: United States
facility: Colorado Otolaryngology Associates LLC
state: Colorado
city: Chicago
country: United States
facility: Chicago Nasal and Sinus Center
state: Illinois
city: Chicago
country: United States
facility: Rush University
state: Illinois
city: New York
country: United States
facility: Mount Sinai
state: New York
city: New York
country: United States
facility: Madison ENT
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Cincinnati
country: United States
facility: University of Cincinnati College of Medicine
state: Ohio
city: Nashville
country: United States
facility: Vanderbilt Asthma, Sinus & Allergy Program
state: Tennessee
city: San Antonio
country: United States
facility: Alamo ENT Associates
state: Texas
Study officials:
affiliation: Aerin Medical
name: Anais Laborde
role: STUDY_DIRECTOR
References:
citation: Pritikin J, Silvers S, Rosenbloom J, Davis B, Signore AD, Sedaghat AR, Tajudeen BA, Schmale I, Lyons J, Corey J, Chandra R. Temperature-controlled radiofrequency device treatment of septal swell bodies for nasal airway obstruction: An open-label, single arm multicenter study. Int Forum Allergy Rhinol. 2023 Oct;13(10):1915-1925. doi: 10.1002/alr.23156. Epub 2023 Mar 27.
citation: Pritikin J, Silvers S, Rosenbloom J, Davis B, Del Signore A, Sedaghat AR, Tajudeen BA, Schmale I, Chandra RK. Twenty-Four-Month Outcomes Following Temperature-Controlled Radiofrequency Treatment for Septal Swell Body Hypertrophy: An Open-Label, Single-Arm Multicenter Study. Int Forum Allergy Rhinol. 2025 Feb 12. doi: 10.1002/alr.23541. Online ahead of print. No abstract available.