Trial Outcomes & Findings for The Vivaer Procedure for Treatment of the Septal Swell Bodies (SWELL) (NCT NCT05099263)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

70 participants

Primary outcome timeframe

3 months (13 weeks) visit following screening

Results posted on

2025-08-28

Participant Flow

Participants were recruited based on physician referral at 9 academic medical centers and clinics between August 25, 2021 and April 28, 2022. The First Participant enrolled on September 14, 2021 and the last participant enrolled on April 28, 2022.

There was no wash out or run in for this study. A subset of study sites were selected to participate in a substudy of the use of CT imaging to assess changes in the SBB after treatment.

Participant milestones

Participant milestones
Measure	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). 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.
Overall Study STARTED	70
Overall Study 3-Month	68
Overall Study 6-Month	65
Overall Study 12-Month	62
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	70

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single Arm - Vivaer Treatment n=70 Participants target population for this study is adults suffering from symptoms attributed to NAO with evidence of SSB obstruction of the airway which may or may not include hypertrophied turbinates. This study requires severe or extreme symptoms demonstrated by a NOSE Scale score ≥ 55 and determination by the investigator that the SSBs are the primary or significant contributor to the nasal obstruction. 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 with temperature control capable of delivering very low doses of energy. The Vivaer ARC Stylus was cleared for use in the United States (U.S.) by the Food and Drug Administration (FDA) under 510(k) K172529 and the Aerin Console was cleared under 510(k) K162810.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	57 Participants n=5 Participants
Age, Categorical >=65 years	13 Participants n=5 Participants
Sex: Female, Male Female	34 Participants n=5 Participants
Sex: Female, Male Male	36 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	60 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	70 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months (13 weeks) visit following screening

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.

Outcome measures

Outcome measures
Measure	Vivaer Procedure n=69 Participants target population for this study is adults suffering from symptoms attributed to NAO with evidence of SSB obstruction of the airway which may or may not include hypertrophied turbinates. This study requires severe or extreme symptoms demonstrated by a NOSE Scale score ≥ 55 and determination by the investigator that the SSBs are the primary or significant contributor to the nasal obstruction.
Nasal Obstruction Symptom Evaluation (NOSE) Scale Mean Change	-45.3 score on a scale Standard Deviation 21.4

SECONDARY outcome

Timeframe: 3 months (13 weeks) visit following baseline

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.

Outcome measures

Outcome measures
Measure	Vivaer Procedure n=69 Participants target population for this study is adults suffering from symptoms attributed to NAO with evidence of SSB obstruction of the airway which may or may not include hypertrophied turbinates. This study requires severe or extreme symptoms demonstrated by a NOSE Scale score ≥ 55 and determination by the investigator that the SSBs are the primary or significant contributor to the nasal obstruction.
Responder Percent	95.7 percentage of responders

SECONDARY outcome

Timeframe: At or following the study procedure up to 3 months.

Population: AEs with possible relationship to device or procedure. There were no SAEs

Frequency of device-related and procedure-related serious adverse events, including frequency of septal perforation during the procedure, through the 3-month evaluation.

Outcome measures

Outcome measures
Measure	Vivaer Procedure n=69 Participants target population for this study is adults suffering from symptoms attributed to NAO with evidence of SSB obstruction of the airway which may or may not include hypertrophied turbinates. This study requires severe or extreme symptoms demonstrated by a NOSE Scale score ≥ 55 and determination by the investigator that the SSBs are the primary or significant contributor to the nasal obstruction.
Number of Participants With Device Related Adverse Events Visual acuity change (transient)	1 Participants
Number of Participants With Device Related Adverse Events Nasal scarring at 3M	2 Participants
Number of Participants With Device Related Adverse Events Nasal bleeding at 1M	1 Participants
Number of Participants With Device Related Adverse Events Nasal Discharge	2 Participants
Number of Participants With Device Related Adverse Events Headache	1 Participants
Number of Participants With Device Related Adverse Events Nasal Congestion/Obstruction	1 Participants
Number of Participants With Device Related Adverse Events Vasovagal reaction	1 Participants
Number of Participants With Device Related Adverse Events No Device or Procedure related Issues	60 Participants

Adverse Events

Vivaer Procedure

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Vivaer Procedure n=69 participants at risk 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). 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.
Eye disorders Visual Acuity Change (Transient)	1.4% 1/69 • Number of events 1 • 2 years and 7.5 months
Skin and subcutaneous tissue disorders Nasal Scarring at 3M	2.9% 2/69 • Number of events 2 • 2 years and 7.5 months
Blood and lymphatic system disorders Nasal Bleeding at 1M	1.4% 1/69 • Number of events 1 • 2 years and 7.5 months
Skin and subcutaneous tissue disorders Nasal Discharge	2.9% 2/69 • Number of events 2 • 2 years and 7.5 months
Nervous system disorders Headache	1.4% 1/69 • Number of events 1 • 2 years and 7.5 months
Respiratory, thoracic and mediastinal disorders Nasal Congestion/Obstruction	1.4% 1/69 • Number of events 1 • 2 years and 7.5 months
Cardiac disorders Vasovagal Reaction	1.4% 1/69 • Number of events 1 • 2 years and 7.5 months

Additional Information

Anais Laborde, Sr. Director of Clinical Operations

Aerin Medical

Phone: 6505189624

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place