Nasal Obstruction
Conditions
Keywords
nasal valve, nasal airway obstruction
Brief summary
This study evaluates subjective and objective measures of treatment outcome after using the Aerin Medical Vivaer™ Stylus to treat nasal obstruction
Detailed description
This is a non-significant risk, prospective, non-randomized study to evaluate subjective and objective measures of nasal obstruction both before and after treatment with the Vivaer Stylus. The Stylus is used to deliver radiofrequency (RF) energy to the nasal valve area to improve symptoms in those diagnosed with nasal airway obstruction.
Interventions
DEVICEVivaer Stylus
Stylus used to deliver low-power, temperature-controlled, radiofrequency energy to the tissues of the internal nasal valve area
Sponsors
Ohio State University
Aerin Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Complaints of nasal obstruction for at least 1 year * Failed maximum medical therapy (4-6 weeks of steroids) * Nasal Obstruction Symptom Evaluation (NOSE) score of ≥ 60 at Baseline * Nasal valve is a primary or significant contributor to the subject's nasal obstruction as determined by the study investigator (based on clinical presentation, physical examination, nasal endoscopy, etc.) and the subject has a positive response to any of the following temporary measures (based on patient history or during office exam): 1. Use of external nasal dilator strips (e.g., Breathe Right Strips) 2. Q-Tip test (manual intranasal lateralization) 3. Use of nasal stents 4. Cottle Maneuver (manual lateral retraction of the cheek)
Exclusion criteria
* Prior surgical treatment of the nasal valve * Rhinoplasty, septoplasty, inferior turbinate reduction or other surgical nasal procedures within the past three (3) months * Severe and/or chronic sinusitis, recurrent sinusitis, or allergies leading to nasal obstruction and currently requiring oral corticosteroid therapy * Severe case of any of the following: septal deviation, turbinate hypertrophy, polyps, or ptotic nose tip believed to be the primary contributor to the subject's nasal obstruction symptoms and warranting surgical intervention * Known or suspected allergies or contraindications to the anesthetic agents and/or antibiotic medications to be used during the study procedure session * Known or suspected to be pregnant, or is lactating * Other medical conditions which in the opinion of the investigator could predispose the subject to poor wound healing or increased surgical risk
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in NOSE Score | Baseline, 90 days | Mean change in Nasal Obstruction Symptom Evaluation (NOSE) score from baseline to 90 days post-study procedure. Improvement (90 day score - baseline score) is signified by a negative value. The Nasal Obstruction Symptom Evaluation (NOSE) scale is a validated disease-specific health status outcomes instrument, used to assess severity of nasal obstruction symptoms. Score ranges from 0 to 100. Higher scores indicate increased symptoms/symptom severity. |
| Change in VAS of Nasal Obstruction | Baseline, 90 days | Change in visual-analog scale (VAS) of nasal obstruction severity as perceived by the subject from baseline to 90 days post-study procedure. Improvement (90-day score - baseline score) is signified by a negative value. The visual-analog scale (VAS) of nasal obstruction is presented to the subject as a 10cm line anchored on each end by verbal descriptors: 0 = No Obstruction and 10 = Completely Obstructed. The subject is asked to place a vertical mark on the line to show the level of nasal obstruction they feel. The distance between 0 and the vertical mark made by the subject is measured and the results is expressed in centimeters. Higher scores indicate more severe obstruction. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Peak Nasal Inspiratory Flow | Baseline, 90 days | Peak inspiratory flow measurements of nasal physical resistance |
Countries
United States
Participant flow
Recruitment details
Patients with a history of chronic nasal obstruction for at least 1 year were prospectively enrolled at this tertiary academic center.
Participants by arm
| Arm | Count |
|---|---|
| Subjects Followed Through 90 Days Patient cohort includes all subjects treated with the Vivaer Stylus who were evaluated 90 days post-treatment | 18 |
| Total | 18 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Failed pre-treatment screening | 1 |
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | Subjects Followed Through 90 Days |
|---|---|
| Age, Continuous | 46.4 years STANDARD_DEVIATION 17.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 18 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Nasal Obstruction Symptom Evaluation (NOSE) score | 78.9 score on a scale STANDARD_DEVIATION 11.6 |
| Race/Ethnicity, Customized Asian | 1 Participants |
| Race/Ethnicity, Customized Black or African American | 1 Participants |
| Race/Ethnicity, Customized White | 16 Participants |
| Region of Enrollment United States | 18 participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 18 |
| other Total, other adverse events | 6 / 18 |
| serious Total, serious adverse events | 0 / 18 |
Outcome results
Primary
Change in NOSE Score
Mean change in Nasal Obstruction Symptom Evaluation (NOSE) score from baseline to 90 days post-study procedure. Improvement (90 day score - baseline score) is signified by a negative value. The Nasal Obstruction Symptom Evaluation (NOSE) scale is a validated disease-specific health status outcomes instrument, used to assess severity of nasal obstruction symptoms. Score ranges from 0 to 100. Higher scores indicate increased symptoms/symptom severity.
Time frame: Baseline, 90 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subjects Followed Through 90 Days | Change in NOSE Score | -44.5 units on a scale | Standard Deviation 27 |
Primary
Change in VAS of Nasal Obstruction
Change in visual-analog scale (VAS) of nasal obstruction severity as perceived by the subject from baseline to 90 days post-study procedure. Improvement (90-day score - baseline score) is signified by a negative value. The visual-analog scale (VAS) of nasal obstruction is presented to the subject as a 10cm line anchored on each end by verbal descriptors: 0 = No Obstruction and 10 = Completely Obstructed. The subject is asked to place a vertical mark on the line to show the level of nasal obstruction they feel. The distance between 0 and the vertical mark made by the subject is measured and the results is expressed in centimeters. Higher scores indicate more severe obstruction.
Time frame: Baseline, 90 days
Population: Includes all subjects treated with the Vivaer Stylus who were evaluated 90 days post-treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subjects Followed Through 90 Days | Change in VAS of Nasal Obstruction | -2.6 units on a scale | Standard Deviation 2.2 |
Other Pre-specified
Change in Peak Nasal Inspiratory Flow
Peak inspiratory flow measurements of nasal physical resistance
Time frame: Baseline, 90 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subjects Followed Through 90 Days | Change in Peak Nasal Inspiratory Flow | 60.2 ml/sec | Standard Deviation 34.5 |
| Subjects Followed Through 90 Days - 90 Day Data | Change in Peak Nasal Inspiratory Flow | 72.4 ml/sec | Standard Deviation 43.7 |