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

NCT05099263 | Completed Results FDA Device

• 1 other identifier: CTP1125
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 9

Brief Summary

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

Conditions

Nasal Obstruction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Responder Percent

  3 months (13 weeks) visit following baseline

• Number of Participants With Device Related Adverse Events

  At or following the study procedure up to 3 months.

Study Arms (1)

Vivaer Procedure

EXPERIMENTAL

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

Interventions

Vivaer Arc Stylus DEVICE

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.

Vivaer Procedure

Eligibility Criteria

• Age: 22 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Rhinoplasty, septoplasty, inferior turbinate (IT) reduction, or other surgical nasal procedures within the preceding 6 months.
• 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.
• Any adjunctive surgical nasal procedure planned on the same day or within 3 months after the Vivaer procedure.
• Known or suspected allergies or contraindications for any general or local anesthetic agents.
• Known or suspected to be pregnant or is lactating.
• Participating in another clinical research study.
• 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.
• Known or suspected regular use of oxymetazoline (Afrin) nasal decongestant or oral steroids.
• For sites participating in the CT substudy only: Active sinus condition (eg, significant sinus diseases, infection or polyp formation) identified by CT.

Sponsors & Collaborators

• Aerin Medical: lead

Study Sites (9)

Colorado Otolaryngology Associates LLC

Colorado Springs, Colorado, 80923, United States

Location

Chicago Nasal and Sinus Center

Chicago, Illinois, 60602, United States

Location

Rush University

Chicago, Illinois, 60612, United States

Location

Mount Sinai

New York, New York, 10009, United States

Location

Madison ENT

New York, New York, 10016, United States

Location

University of Rochester

Rochester, New York, 14627, United States

Location

University of Cincinnati College of Medicine

Cincinnati, Ohio, 45267, United States

Location

Vanderbilt Asthma, Sinus & Allergy Program

Nashville, Tennessee, 37203, United States

Location

Alamo ENT Associates

San Antonio, Texas, 78258, United States

Location

Related Publications (2)

• 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.

  PMID: 36908245 RESULT

• 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.

  PMID: 39936254 RESULT

MeSH Terms

Conditions

Nasal Obstruction

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Airway Obstruction; Respiratory Insufficiency; Respiration Disorders; Otorhinolaryngologic Diseases

Results Point of Contact

• Title: Anais Laborde, Sr. Director of Clinical Operations
• Organization: Aerin Medical

alaborde@aerinmedical.com

6505189624

Study Officials

• Anais Laborde

  Aerin Medical

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2021
• First Posted: October 29, 2021
• Study Start: September 14, 2021
• Primary Completion: April 27, 2022
• Study Completion: October 16, 2024
• Last Updated: August 28, 2025
• Results First Posted: August 21, 2024

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)