search
Back to results

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

Primary Purpose

Nasal Obstruction

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vivaer Arc Stylus
Sponsored by
Aerin Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nasal Obstruction

Eligibility Criteria

22 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Colorado Otolaryngology Associates LLC
  • Chicago Nasal and Sinus Center
  • Rush University
  • Mount Sinai
  • Madison ENT
  • University of Rochester
  • University of Cincinnati College of Medicine
  • Vanderbilt Asthma, Sinus & Allergy Program
  • Alamo ENT Associates

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vivaer Procedure

Arm Description

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
October 11, 2021
Last Updated
April 14, 2023
Sponsor
Aerin Medical
search

1. Study Identification

Unique Protocol Identification Number
NCT05099263
Brief Title
The Vivaer Procedure for Treatment of the Septal Swell Bodies (SWELL)
Acronym
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 14, 2021 (Actual)
Primary Completion Date
April 27, 2022 (Actual)
Study Completion Date
October 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aerin Medical

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasal Obstruction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vivaer Procedure
Arm Type
Experimental
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
Vivaer Arc Stylus
Intervention Description
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.
Primary Outcome Measure Information:
Title
Nasal Obstruction Symptom Evaluation (NOSE) Scale Mean Change
Description
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.
Time Frame
3 months (13 weeks) visit following screening
Secondary Outcome Measure Information:
Title
Responder Percent
Description
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.
Time Frame
3 months (13 weeks) visit following baseline
Title
Device Related Adverse Events
Description
Frequency of device-related and procedure-related serious adverse events, including frequency of septal perforation during the procedure, through the 3-month evaluation.
Time Frame
At or following the study procedure up to 3 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anais Laborde
Organizational Affiliation
Aerin Medical
Official's Role
Study Director
Facility Information:
Facility Name
Colorado Otolaryngology Associates LLC
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80923
Country
United States
Facility Name
Chicago Nasal and Sinus Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60602
Country
United States
Facility Name
Rush University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10009
Country
United States
Facility Name
Madison ENT
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14627
Country
United States
Facility Name
University of Cincinnati College of Medicine
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Vanderbilt Asthma, Sinus & Allergy Program
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Alamo ENT Associates
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No data collected will be shared with other researchers participating in the study.

Learn more about this trial

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

We'll reach out to this number within 24 hrs