VivAer: A Correlation Between Symptom Scores and Objective Findings
Phase: NA
Conditions: Nasal Obstruction, Medically Unexplained Symptoms, Airway Obstruction, Airway Remodeling
Sponsor: Endeavor Health

VIVAER: CORRELATION OF SYMPTOMS & FINDINGS 
Protocol Version 1; Dated: February 3rd, 2022 
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VivAer: A Correlation between Symptom Scores and Objective 
Findings 
 
Principal Investigator: Auddie M. Sweis, MD 
Co-Investigator: Joseph R. Raviv, MD 
Department of Otolaryngology 
NorthShore University HealthSystem 
Protocol Version 1 
Dated: February 3, 2022 
 
 
 

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Nasal obstruction that is not responding to appropriate medical therapy may be an indication for 
surgery. Recently, the minimally invasive VivAer procedure may also be an option. 
In a multi-center, prospective study, 89% of patients who underwent the VivAer 
procedure reported improved sleep quality, and 94% of patients reported improved ability to 
breathe through their nose during exercise or exertion. Furthermore, there was a 97% overall 
response rate with a 67% reduction in Nasal Obstruction Symptom Evaluation (NOSE). No 
serious adverse events were reported with the use of VivAer.1,2 While impressive, these positive 
outcomes were measured using patient symptom scores. 
In patients with nasal obstruction, we propose to assess the objective improvement in 
nasal airflow secondary to the VivAer procedure. In an open-label, prospective single center 
study, patient questionnaires and objective measurements prior to and after the VivAer procedure 
will be conducted. 
BACKGROUND AND SIGNIFICANCE 
The VivAer intranasal remodeling treatment is a minimally invasive procedure, which uses a 
stylus to deliver controlled and targeted low energy radiofrequency heating to the nasal sidewall 
to gently reshape the tissues. Unlike most established treatments, it is an outpatient intervention 
administered under local anesthesia. The investigators of this study are each fellowship trained in 
rhinology and skull base surgery and not only understand which patients would benefit most 
from this treatment, but also be able to deliver the treatment safely. 
Specific Aims: 
 Eligible patients will show significant clinical improvement on the following patient 
questionnaires and on objective measurements. 
 

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Specific Aim 2: 
 Improvement in Nasal Obstructive Symptom Evaluation (NOSE) score  
Specific Aim 3: 
 Improvement in SinoNasal Outcome Test (SNOT)-22 score  
RESEARCH DESIGN AND METHODS 
Study Design: 
This is a prospective, non-randomized trial to assess objective improvement in nasal patency 
after undergoing treatment of the nasal valve with VivAer. Up to twenty-six subjects will be 
enrolled in this trial. Patients presenting with nasal obstruction and no notable septal deviation 
will be instructed to complete four weeks of intranasal steroid sprays. After patients complete the 
intranasal steroid spray, they will return to the clinic to assess nasal patency. If nasal obstruction 
symptoms persist, their eligibility for the VivAer procedure is assessed.  The inclusion and 
exclusion criteria outlined below will be reviewed. If the patient is eligible and interested in 
receiving the VivAer procedure, they will be consented and receive a date to undergo the 
procedure. At the procedure date, they will perform baseline peak nasal inspiratory flow (PNIF) 
measurements and complete baseline Sino-Nasal Outcome Test (SNOT-22) scores and Nasal 
Obstructive Symptom Evaluation (NOSE) scores. After the procedure, subjects will be off 
steroid sprays for 2 weeks and will only use nasal saline irrigations during the procedure-
recovery period.  Subjects will return to clinic for evaluation at 4 weeks, 12 weeks and 24 weeks 
post procedure and during each of these visits will complete interval PNIF measurements, 
SNOT-22 scores, and NOSE scores. 
 
 

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Eligibility: 
Inclusion Criteria: 
1. Adults 18 years and older seeking treatment for nasal obstruction and willing to undergo an 
office‐based procedure. 
2. Nasal obstruction, defined as ≥60 by the NOSE scale. 
3. The nasal valve is the primary or significant contributor to the subject's nasal obstruction as 
determined by the investigator, based on clinical presentation, physical examination, or 
nasal endoscopy. 
4. Subjects has symptomatic improvement with use of external or internal nasal dilators, Q‐
Tip or curette test (manual intranasal lateralization), or the Cottle Maneuver (manual lateral 
retraction of the cheek). 
5. Subject experienced minimal symptomatic improvement after the four-week fluticasone 
steroid nasal spray regimen. 
Exclusion Criteria: 
1. Prior surgery to the nasal valve, rhinoplasty, septoplasty, inferior turbinate reduction or 
other surgical nasal procedures within the past 12 months. 
2. Severe and/or chronic sinusitis, recurrent sinusitis, or allergies leading to nasal obstruction 
and currently requiring oral corticosteroid therapy. 
a. Treated allergic rhinitis is not an exclusion criteria and eligible patients will be permitted 
to continue use of oral and/or topical medications throughout the trial. 
3. Severe case of any of the following; septal deviation, turbinate hypertrophy, polyps, or 
ptotic nasal tip believed to be the primary contributor to the subject's nasal obstruction 
symptoms and warranting surgical intervention. 

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4. Known or suspected allergies or contraindications to the anesthetic agents and/or antibiotic 
medications to be used during the study procedure session. 
5. Known or suspected pregnancy, or lactation. 
6. Other medical conditions that the investigator believed would predispose subject to poor 
wound healing or increased surgical risk. 
Study Calendar 
 
Consent 
Procedure Four Week 
Follow-up 
(One Month; 
+/- one week) 
Twelve Week 
Follow-up 
(Three 
Months;  
+/- 2 weeks) 
Twenty-four 
Week 
Follow-up 
(Six Months; 
+/- 2 weeks ) 
Exam 
X 
 
X 
X 
X 
Determine 
Eligibility 
X 
 
 
 
 
Procedure 
 
X 
 
 
 
PNIF 
Measurements 
X 
 
X 
X 
X 
SNOT-22 
Questionnaire 
X 
 
X 
X 
X 
NOSE 
Questionnaire 
X 
 
X 
X 
X 
Adverse Event 
Monitoring 
 
X 
X 
X 
X 
 
Description of Procedure  
The region of the upper lateral cartilage is anesthetized intranasally using either topical lidocaine 
4% or tetracaine 4%. Lidocaine 1% with epinephrine is subsequently injected to achieve 
complete local anesthesia. 
Bilateral radiofrequency treatment is applied in a single visit using Aerin Medical's 
VivAer Stylus with a Model ORA‐50S generator (Fig. 1) at a setting of 60°C and 4 watts. The 
stylus is placed intranasally onto the mucosa overlying the lower edge of the upper lateral 
cartilage and three non-overlapping loci along the nasal valve angle are treated on each side 

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(Fig. 2). No incisions are made. Tissue temperature feedback is constantly provided by the stylus 
before, during and after treatment to allow the generator to modulate power for maintaining 
treatment temperature at 60°C, and procedure safety. 
Each treatment cycle consists of an 18‐second treatment pulse and 12‐second cooling 
time while applying continuous upward pressure with the stylus in an outward direction 
perpendicular to the upper lateral cartilage at each position. A standardized approach is used 
based on animal and human pilot studies where temperature and duration parameters were 
determined for optimal safety and efficacy 
Efficacy endpoint will be determined at 26 weeks using the NOSE and SNOT survey 
scores. Scores are assessed at baseline, 4, 12, and 26 weeks post procedure and the responder 
rate, defined as a ≥15‐point decrease, was determined. In two studies, the minimally clinically 
important difference (MCID) in the NOSE score was calculated as approximately 4 to 6.3 points, 
so a ≥15‐point was selected as the minimal clinically relevant change.3,4 
Additionally, peak nasal inspiratory flow (PNIF) meters will be used at baseline, 4, 12, 
and 26 weeks. 
Statistical Analysis: 
Patient characteristics, objective measurements and patient questionnaires will be summarized 
using descriptive statistics such as mean with standard deviation and mean or frequency with 
percentage. Comparisons of outcomes measured between baseline and postop will be assessed 
using the paired t-test or McNemar’s test. A total of 26 patients is required to achieve 80% power 
for a paired t-test with a significance level of α=0.05 and a moderate effect size of d=0.50. All 
statistical analysis will be performed using SAS 9.4 (SAS Institute, Cary, NC) with two-sided 
tests and p<0.05 considered statistically significant. 

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FORESEEABLE RISKS AND DISCOMFORTS 
Discomfort that is expected in the treatment area rarely will include inflammation/redness, 
swelling/edema, blanching, numbness, bruising, soreness/pain, bleeding at local anesthetic 
injection site, bleeding at the treatment site, nasal obstruction from tissue edema, disruption of 
mucosal flow/crusting. 
Potential risks that have not been reported with VivAer but are theoretical risks after this 
treatment include the following: infection, bleeding greater than anticipated by the investigator, 
scar formation with subsequent nasal obstruction, sensory changes at the treatment site. 
EXPECTED BENEFITS 
It is anticipated that this procedure will improve nasal breathing. VivAer is minimally invasive. 
The objective data received from this study will help clinicians provide better guidance to 
patients interested in receiving this treatment. 
EQUITABLE SELECTION OF SUBJECTS  
Patients will not be categorically excluded from this research. The study population will be 
limited to those who are eligible based on the inclusion criteria for this study. If an eligible 
patient speaks another language aside from English, the study team will follow the institutions 
short form consent process.  This will ensure all patients have the equitable right to participate in 
this research, while maintaining their comprehension of the study. 
RECRUITMENT PROCEDURES  
Physician’s practices will be the basis of recruitment for this clinical trial.  
 
 

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CONSENT PROCEDURES 
All subjects will receive the consent form for the study. This document will be read by the 
patients and reviewed by the patient with a licensed physician investigator and/or research study 
staff prior to participating in the study. The patient will be given as much time as they need to 
review the consent. Joseph R. Raviv MD, Auddie M. Sweis MD, or another licensed physician 
investigator will clarify any questions, concerns, or ambiguities prior to the patient signing 
consent. Patients will sign informed consent and only then will begin participation in the study. 
If new information is ascertained during the study, we will modify our consent and re-consent 
our patients.  
DATA AND SAFETY MONITORING  
Each site will conduct weekly research meetings with co-investigators and study staff to review 
study progress, including recruitment strategies, enrollment numbers, protocol issues, and safety 
issues. The PIs will participate in monthly conference calls regarding study progress.  
Documentation of the presence of any side effect or adverse event will be completed at 
every visit using the adverse event classification available in appendix 1. Patients will be asked 
to contact an investigator or study staff member at any time concerning adverse events or 
worsening symptoms. All treatment related Serious Adverse Events (SAE) will be documented 
and reported immediately to the NorthShore IRB in line with institutional and regulatory 
requirements. In the event that a patient becomes ill or injured as a direct result of participation 
in the research study, necessary medical care will be available. All SAEs will be followed to 
resolution or stabilization.  
 

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MONITORING AND QUALITY ASSURANCE  
Auddie Sweis, MD and Joseph Raviv, MD will oversee and monitor the study at an ongoing 
basis to ensure that it is being executed accurately and per protocol. Both will be responsible for 
monitoring the data collected, and the reporting of study-related adverse events to the IRB in 
accordance with adverse event reporting policies. 
PRIVACY AND CONFIDENTIALITY 
Medical information produced by this study will be stored in the investigator’s file and identified 
by code number only. The code key connecting a specific name to specific information will be 
kept in a separate, secure location. Information contained in the records will not be given to 
anyone unaffiliated with NorthShore in a form that could identify the subject without the subjects 
written consent, except as described in the consent form or as required by law. It is possible that 
medical and research records, including sensitive information and/or identifying information, 
may be inspected and/or copied by federal or state government agencies, or hospital accrediting 
agencies, in the course of carrying out their duties. However, they are required to maintain 
confidentiality in accordance with laws and policies of the Hospital.  
 
 

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REFERENCES: 
1. Jacobowitz, O., Driver, M. and Ephrat, M. (2019), In-office treatment of nasal valve 
obstruction using a novel, bipolar radiofrequency device. Laryngoscope Investigative 
Otolaryngology, 4: 211-217. https://doi.org/10.1002/lio2.247 
2. Ephrat, M, Jacobowitz, O, Driver, M. Quality-of-life impact after in-office treatment of 
nasal valve obstruction with a radiofrequency device: 2-year results from a multicenter, 
prospective clinical trial. Int Forum Allergy Rhinol. 2021; 11: 755– 765. 
https://doi.org/10.1002/alr.22667 
3. Stewart M, Smith T, Weaver E, et al. Outcomes after nasal septoplasty: results from the 
Nasal Obstruction Septoplasty Effectiveness (NOSE) study. Otolaryngol Head Neck Surg 
2004;130(3):283–290. [PubMed] [Google Scholar] 
4. Lipan M, Most S. Development of a severity classification system for subjective nasal 
obstruction. JAMA Facial Plast Surg 2013;15(5):358–361. [PubMed] [Google Scholar] 
 
 

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Appendices: 
Appendix 1: 
Adverse Events Definitions 
1. Adverse Event (AE) 
a. Any untoward medical occurrence, unintended disease or injury or any untoward clinical 
signs (including an abnormal laboratory finding) in subjects, users or other persons 
whether or not related to the investigational medical device. 
2. Serious Adverse Event (SAE): any AE that  
a. Led to death, or  
b. Led to serious deterioration in the health of the subject, that either:  
i. Resulted in a life-threatening illness or injury, or  
ii. Resulted in a permanent impairment of a body structure or a body function, or  
iii. Required in-patient or prolonged hospitalization, or  
iv. Resulted in medical or surgical intervention to prevent life-threatening illness or 
injury or permanent impairment to a body structure or a body function, or  
c. Led to fetal distress, fetal death, or a congenital abnormality or birth defect.  
3. Unanticipated Adverse Device Effect (UADE) 
a. Unanticipated adverse device effect means any serious adverse effect on health or safety 
or any life-threatening problem or death caused by, or associated with, a device, if that 
effect, problem, or death was not previously identified in nature, severity, or degree of 
incidence in the investigational plan or application (including a supplementary plan or 
application), or any other unanticipated serious problem associated with a device that 
relates to the rights, safety, or welfare of subjects. 
 
 

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4. Severity 
a. The Investigator or designee is required to determine severity of the AEs reported. The 
following definitions are used for determination:  
Mild – Easily tolerated by the subject, causing minimal discomfort and not 
interfering with everyday activities. These events generally do not require 
treatment.  
Moderate – Sufficiently discomforting to interfere with normal everyday 
activities. These events are usually relieved by simple therapeutic measures.  
Severe – Prevents normal, everyday activities. These events may require 
systemic drug therapy, other medical treatment, or return to the operating room. 
5. Relationship to Investigational Device 
a. The Investigator or designee is required to determine the relationship of each AE to the 
investigational device. The following definitions are used for determination:  
i. Definite – The AE follows a known or expected response pattern to the device 
and the physician confirms the relationship through further testing or evidence.  
ii. Probable – The AE follows a known or expected response pattern to the device.  
iii. Possible – The AE follows a known or expected response pattern to the device 
but could readily have been produced by a number of other factors.  
iv. None – An AE for which sufficient information exists to indicate that the 
etiology is unrelated to the device; the AE is readily explained by the subject’s 
clinical state or other therapies.