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

Nasal Obstruction Clinical Trial

— SWELL  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05099263
• Other study ID #: CTP1125
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 14, 2021
• Est. completion date: October 31, 2024

Study information

• Verified date: April 2023
• Source: Aerin Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 70
• Est. completion date: October 31, 2024
• Est. primary completion date: April 27, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Nasal Obstruction

Intervention

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.

Locations

Country	Name	City	State
United States	Chicago Nasal and Sinus Center	Chicago	Illinois
United States	Rush University	Chicago	Illinois
United States	University of Cincinnati College of Medicine	Cincinnati	Ohio
United States	Colorado Otolaryngology Associates LLC	Colorado Springs	Colorado
United States	Vanderbilt Asthma, Sinus & Allergy Program	Nashville	Tennessee
United States	Madison ENT	New York	New York
United States	Mount Sinai	New York	New York
United States	University of Rochester	Rochester	New York
United States	Alamo ENT Associates	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Aerin Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months (13 weeks) visit following screening
Secondary	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.	3 months (13 weeks) visit following baseline
Secondary	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.