Nasal Obstruction
Conditions
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.
Interventions
DEVICEVivaer 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.
Sponsors
Aerin Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to 85 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nasal Obstruction Symptom Evaluation (NOSE) Scale Mean Change | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Responder Percent | 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. |
| Number of Participants With Device Related Adverse Events | At or following the study procedure up to 3 months. | Frequency of device-related and procedure-related serious adverse events, including frequency of septal perforation during the procedure, through the 3-month evaluation. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Single Arm - Vivaer Treatment 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. | 70 |
| Total | 70 |
Baseline characteristics
| Characteristic | Single Arm - Vivaer Treatment |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 13 Participants |
| Age, Categorical Between 18 and 65 years | 57 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 60 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Region of Enrollment United States | 70 participants |
| Sex: Female, Male Female | 34 Participants |
| Sex: Female, Male Male | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 69 |
| other Total, other adverse events | 9 / 69 |
| serious Total, serious adverse events | 0 / 69 |
Outcome results
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. 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.
Time frame: 3 months (13 weeks) visit following screening
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vivaer Procedure | Nasal Obstruction Symptom Evaluation (NOSE) Scale Mean Change | -45.3 score on a scale | Standard Deviation 21.4 |
Secondary
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.
Time frame: At or following the study procedure up to 3 months.
Population: AEs with possible relationship to device or procedure. There were no SAEs
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vivaer Procedure | Number of Participants With Device Related Adverse Events | Visual acuity change (transient) | 1 Participants |
| Vivaer Procedure | Number of Participants With Device Related Adverse Events | Nasal scarring at 3M | 2 Participants |
| Vivaer Procedure | Number of Participants With Device Related Adverse Events | Nasal bleeding at 1M | 1 Participants |
| Vivaer Procedure | Number of Participants With Device Related Adverse Events | Nasal Discharge | 2 Participants |
| Vivaer Procedure | Number of Participants With Device Related Adverse Events | Headache | 1 Participants |
| Vivaer Procedure | Number of Participants With Device Related Adverse Events | Nasal Congestion/Obstruction | 1 Participants |
| Vivaer Procedure | Number of Participants With Device Related Adverse Events | Vasovagal reaction | 1 Participants |
| Vivaer Procedure | Number of Participants With Device Related Adverse Events | No Device or Procedure related Issues | 60 Participants |
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 (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.
Time frame: 3 months (13 weeks) visit following baseline
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vivaer Procedure | Responder Percent | 95.7 percentage of responders |