Nasal Obstruction
Conditions
Keywords
Nasal valve, Nasal airway obstruction
Brief summary
Post-market study to continue to evaluate the effectiveness of the Vivaer® ARC Stylus for nasal airway obstruction
Detailed description
Prospective, Multicenter, Non-randomized Study of the Aerin Medical Vivaer® ARC Stylus for Nasal Airway Obstruction to continue to evaluate the effectiveness of the Vivaer® ARC Stylus for treating the nasal valve area to improve symptoms in those diagnosed with nasal airway obstruction.
Interventions
DEVICEVivaer Stylus
Delivery of low-power, temperature-controlled, radiofrequency energy to the tissues of the internal nasal valve area
Sponsors
Aerin Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age 18 or older 2. Willing and able to provide informed consent 3. Willing and able to comply with the study protocol 4. Seeking treatment for nasal obstruction 5. NOSE score of ≥ 60 at Baseline 6. 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 office exam): * Use of external nasal dilator strips (e.g., Breathe Right Strips) * Q-Tip test (manual intranasal lateralization) * Use of nasal stents * Cottle Maneuver (manual lateral retraction of the cheek)
Exclusion criteria
1. Prior surgical treatment of the nasal valve 2. Rhinoplasty, septoplasty, inferior turbinate reduction or other surgical nasal procedures within the past three (3) months 3. Anatomy that requires an adjunctive surgical nasal procedure on the same day or 3 months after the Vivaer procedure 4. Medical conditions which in the opinion of the treating physician would predispose the subject to poor wound healing or increased surgical risk.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Nasal Obstructive Symptom Evaluation (NOSE) Scores From Baseline to 3 Months | 3 Month | Mean change in NOSE score from Baseline to 3 months.Scores may range from the best score of 0, meaning no nasal obstructive symptoms to the worst score of 100, meaning severe nasal obstructive symptoms. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Subject-reported Visual Analog Scale (VAS) Pain Scores in Relation to the Area Treated by the Study Procedure | 3 months post study procedure | The Pain VAS will be used to rate pain associated with the treatment (Hawker, Mian et al. 2011). Subjects are asked to mark their pain level on a 10 cm line anchored by verbal descriptors: 0 = no pain and 10 = worst pain imaginable. The study staff will measure with a metric ruler from the 0, the beginning of the line, to the vertical mark made by the subject. The result, expressed in millimeters, will represent the subject's VAS Pain Score with 100 being the worst pain imaginable. |
| Subject Reported Change in Medication Use for Nasal Obstruction Symptoms | 24 Month | Evaluate change (reduction) in medication used for nasal obstruction symptoms from Baseline to follow up timepoints post study procedure of 3 months, 6 months, 12 months and 24 months |
| Change in Nasal Obstructive Symptom Evaluation (NOSE)Scores From Baseline to 24 Months - Analysis | 24 Months | Mean change in NOSE score from Baseline to 24 months post study procedure. Scores may range from the best score of 0, meaning no nasal obstructive symptoms to the worst score of 100, meaning sever nasal obstructive symptoms |
Countries
United States
Participant flow
Recruitment details
Study enrollment was Up to 125 treated patients to be enrolled in the study at up to 20 sites (medical clinics) in the United States. Recruitment occurred 01FEB2020 - 26AUG2020.
Participants by arm
| Arm | Count |
|---|---|
| Vivaer Treatment Intervention: Procedure: thermal treatment of submucosal tissue including cartilage in the internal nasal valve area
Vivaer Stylus: Delivery of low-power, temperature-controlled, radiofrequency energy to the tissues of the internal nasal valve area | 122 |
| Total | 122 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Completed through 24M but not interested in extension to 36M | 3 |
| Overall Study | Data missing for full evaluation | 5 |
| Overall Study | Death due to COVID-19 | 1 |
| Overall Study | Lost to Follow-up | 17 |
| Overall Study | Received Treatment Outside of Study that could affect study results | 2 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Vivaer Treatment |
|---|---|
| Additional Nasal Obstruction Diagnosis Nasal Polyps | 3 Participants |
| Additional Nasal Obstruction Diagnosis Nasal Valve Stenosis | 64 Participants |
| Additional Nasal Obstruction Diagnosis Septal Deviation | 34 Participants |
| Additional Nasal Obstruction Diagnosis Septal Turbinate (Nasal Septal Body) | 37 Participants |
| Additional Nasal Obstruction Diagnosis Turbinate Enlargement | 31 Participants |
| Age, Customized <60 years | 83 Participants |
| Age, Customized >=60 years | 39 Participants |
| Baseline NOSE Scale Score | 80.3 units on a scale STANDARD_DEVIATION 12.6 |
| Body Mass Index | 27.6 Kg/m^2 STANDARD_DEVIATION 6.7 |
| History of Nasal Surgery | 67 Participants |
| Nasal Valve Collapse Mechanism Bilateral Dynamic | 68 Participants |
| Nasal Valve Collapse Mechanism Bilateral Static | 47 Participants |
| Nasal Valve Collapse Mechanism Unilateral Dynamic | 2 Participants |
| Nasal Valve Collapse Mechanism Unilateral Dynamic and Unilateral Static | 2 Participants |
| Nasal Valve Collapse Mechanism Unilateral Static | 1 Participants |
| Nasal Valve Collapse Mechanism Unreported | 2 Participants |
| Race/Ethnicity, Customized Asian | 3 Participants |
| Race/Ethnicity, Customized Asian, White | 2 Participants |
| Race/Ethnicity, Customized Black or African American | 4 Participants |
| Race/Ethnicity, Customized Black or African American, White | 1 Participants |
| Race/Ethnicity, Customized Declined Available Choices | 5 Participants |
| Race/Ethnicity, Customized White | 107 Participants |
| Sex: Female, Male Female | 64 Participants |
| Sex: Female, Male Male | 58 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 122 |
| other Total, other adverse events | 0 / 122 |
| serious Total, serious adverse events | 1 / 122 |
Outcome results
Primary
Change in Nasal Obstructive Symptom Evaluation (NOSE) Scores From Baseline to 3 Months
Mean change in NOSE score from Baseline to 3 months.Scores may range from the best score of 0, meaning no nasal obstructive symptoms to the worst score of 100, meaning severe nasal obstructive symptoms.
Time frame: 3 Month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Protocol Eligible Subjects | Change in Nasal Obstructive Symptom Evaluation (NOSE) Scores From Baseline to 3 Months | -47.6 score on a scale | Standard Error 26.1 |
Other Pre-specified
Change in Nasal Obstructive Symptom Evaluation (NOSE)Scores From Baseline to 24 Months - Analysis
Mean change in NOSE score from Baseline to 24 months post study procedure. Scores may range from the best score of 0, meaning no nasal obstructive symptoms to the worst score of 100, meaning sever nasal obstructive symptoms
Time frame: 24 Months
Population: A total of 1010 patients reached 2 year follow-up, of which, 12 had an additional nasal procedure and were reviewed separately
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Protocol Eligible Subjects | Change in Nasal Obstructive Symptom Evaluation (NOSE)Scores From Baseline to 24 Months - Analysis | 57 score on a scale | Standard Error 2.8213 |
Other Pre-specified
Subject Reported Change in Medication Use for Nasal Obstruction Symptoms
Evaluate change (reduction) in medication used for nasal obstruction symptoms from Baseline to follow up timepoints post study procedure of 3 months, 6 months, 12 months and 24 months
Time frame: 24 Month
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Protocol Eligible Subjects | Subject Reported Change in Medication Use for Nasal Obstruction Symptoms | 31 Participants |
| Subjects Using Nasal Sprays for NAO Symptoms | Subject Reported Change in Medication Use for Nasal Obstruction Symptoms | 34 Participants |
Other Pre-specified
Subject-reported Visual Analog Scale (VAS) Pain Scores in Relation to the Area Treated by the Study Procedure
The Pain VAS will be used to rate pain associated with the treatment (Hawker, Mian et al. 2011). Subjects are asked to mark their pain level on a 10 cm line anchored by verbal descriptors: 0 = no pain and 10 = worst pain imaginable. The study staff will measure with a metric ruler from the 0, the beginning of the line, to the vertical mark made by the subject. The result, expressed in millimeters, will represent the subject's VAS Pain Score with 100 being the worst pain imaginable.
Time frame: 3 months post study procedure
Population: All treated subjects VAS score at 3 months post procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Protocol Eligible Subjects | Subject-reported Visual Analog Scale (VAS) Pain Scores in Relation to the Area Treated by the Study Procedure | 4.5 millimeters | Standard Deviation 8.8 |