The Vivaer Procedure for Treatment of the Septal Swell Bodies (SWELL) (SWELL)

The Vivaer Procedure for Treatment of the Septal Swell Bodies for Airway Obstruction - A Prospective Open-Label Multicenter Study (SWELL)

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

Study Overview

• Status: Completed
• Conditions: Nasal Obstruction
• Intervention / Treatment: Device: Vivaer Arc Stylus

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.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Colorado Springs, Colorado, United States, 80923
      • Colorado Otolaryngology Associates LLC
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University
    • Chicago, Illinois, United States, 60602
      • Chicago Nasal and Sinus Center
  • New York
    • New York, New York, United States, 10016
      • Madison ENT
    • New York, New York, United States, 10009
      • Mount Sinai
    • Rochester, New York, United States, 14627
      • University of Rochester
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • University of Cincinnati College of Medicine
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Vanderbilt Asthma, Sinus & Allergy Program
  • Texas
    • San Antonio, Texas, United States, 78258
      • Alamo ENT Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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 will undergo bilateral treatment of the nasal airway in a single study procedure session. Each side of the nose will be treated as follows: • Two (2) to six (6) nonoverlapping applications of RF energy are performed at the SSB per nostril. The default treatment settings will be used for the study: 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 (36 months).

Device: 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 airway in a single study session.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nasal Obstruction Symptom Evaluation (NOSE) Scale Mean Change	The primary endpoint is improvement in self-reported Nasal Obstruction Symptom Evaluation (NOSE) Scale score from baseline recorded at the screening evaluation to 13 weeks after the procedure. The NOSE Scale is a validated disease-specific health status instrument used by clinicians to measure the outcome of participants treated for nasal obstruction.43 The NOSE Scale consists of 5 items, each scored using a 5-point Likert scale to make a total score range of 0 through 100, where higher scores indicate worse obstruction. Severity of symptoms can be classified as mild (range, 5-25), moderate (range, 30-50), severe (range, 55-75), or extreme (range, 80-100) nasal obstruction, based on responses to the NOSE Scale survey.	3 months (13 weeks) visit following screening

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Responder Percent	Responder percent: A responder is defined as at least 1 NOSE Scale class improvement or an improvement (decrease) in NOSE Scale score of 20% or more from baseline to 13 weeks after the procedure (eg, going from a score in the severe range (55-75) at preprocedure to a score in the moderate range (30-50) at the 3-month evaluation), or an improvement (decrease) in NOSE Scale score of 20% or more from screening at the 3-month evaluation.	3 months (13 weeks) visit following baseline
Number of Participants With Device Related Adverse Events	Frequency of device-related and procedure-related serious adverse events, including frequency of septal perforation during the procedure, through the 3-month evaluation.	At or following the study procedure up to 3 months.

Collaborators and Investigators

• Sponsor: Aerin Medical
• Investigators: Study Director: Anais Laborde, Aerin Medical

Publications and helpful links

General Publications

• 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.
• 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 Jun;15(6):651-654. doi: 10.1002/alr.23541. Epub 2025 Feb 12. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2021
• Primary Completion (Actual): April 27, 2022
• Study Completion (Actual): October 16, 2024

Study Registration Dates

• First Submitted: October 11, 2021
• First Submitted That Met QC Criteria: October 26, 2021
• First Posted (Actual): October 29, 2021

Study Record Updates

• Last Update Posted (Estimated): August 28, 2025
• Last Update Submitted That Met QC Criteria: August 13, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Nose Diseases; Otorhinolaryngologic Diseases; Respiratory Insufficiency; Airway Obstruction; Nasal Obstruction
• Other Study ID Numbers: CTP1125

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No data collected will be shared with other researchers participating in the study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes