Nasal Obstruction
Conditions
Keywords
Nasal valve, Nasal airway obstruction
Brief summary
Evaluation of the Aerin Medical Device used for the treatment of nasal obstruction.
Detailed description
This is a non-significant risk, prospective, multi-center, non-randomized study to evaluate the safety and efficacy of the Aerin Medical device (Vivaer Stylus) when used to deliver radiofrequency (RF) energy to 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
22 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Seeking treatment for nasal obstruction and willing to undergo an office-based procedure * 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 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
* Prior surgical treatment of the nasal valve * Rhinoplasty, septoplasty, inferior turbinate reduction or other surgical nasal procedures within the past twelve (12) months * Chronic sinusitis, recurrent sinusitis, or allergies leading to nasal obstruction * Septal deviation, turbinate hypertrophy, polyps, or ptotic nose tip believed to be a significant contributor to the subject's nasal obstruction symptoms * Known or suspected allergies or contraindications for any general or local anesthetic agents and / or any antibiotic medications * 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 |
|---|---|---|
| Improvement in NOSE Score | Baseline, 26 weeks | Mean change in Nasal Obstruction Symptom Evaluation (NOSE) score from baseline to 26 weeks post-study procedure. Improvement (baseline score - 26-week score) is signified by a positive 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| NOSE Responder Rate | Baseline, 26 weeks | Percent subjects who are responders to therapy; responder is defined as a treated subject who experiences at least a 15-point improvement in NOSE score from baseline to 26 weeks post treatment. |
| Percentage of Participants With Treatment-Related Adverse Events (Safety) | Baseline through 26 weeks | Characterization of the type and frequency of treatment-related adverse events reported during or following the study procedure, throughout the follow-up period. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Subject-reported Pain Related to the Study Procedure, as Reported on 100mm Visual Analog Scale | Immediately after study procedure, 4-weeks | Procedure-related pain as reported by the subject using a 100mm Visual Analog Scale (VAS), immediately post-procedure and at the 4-week follow-up visit. Higher scores indicate more severe pain. The Pain VAS is presented to the subject as a 100mm line anchored on each end by verbal descriptors: 0 = no pain and 100 = worse pain imaginable. The distance between 0 and the vertical mark made by the subject is measured and the result is expressed in millimeters. |
| Subject Satisfaction | 26 weeks | Study-specific survey to assess patient satisfaction with the discomfort of the procedure and recovery period, as well as their perceived results. The survey included 5 questions related to tolerability of the procedure, ease of recovery, change in breathing, satisfaction with treatment, and willingness to recommend treatment. Each question was scored on a 10-point scale, with 1 indicating the most negative response to the question (e.g., very bad, much worse, or very dissatisfied) and 10 indicating the most favorable rating (e.g., hardly noticeable, much better, or very satisfied). Each question was individually scored and reported. |
Countries
United States
Participant flow
Recruitment details
Patients in the specialist's clinic with symptoms associated with nasal airway obstruction were approached for possible participation. Following completion of the informed consent process, baseline evaluation was conducted.
Pre-assignment details
Four potential subjects failed to meet one or more of the inclusion/exclusion criteria. One additional subject met all criteria, but other health issues precluded commitment to the study.
Participants by arm
| Arm | Count |
|---|---|
| Vivaer Stylus 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 | 50 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | Vivaer Stylus |
|---|---|
| Age, Continuous | 50.9 years STANDARD_DEVIATION 12.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 48 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Nasal Obstruction Symptom Evaluation (NOSE) score | 79.9 units on a scale STANDARD_DEVIATION 10.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 49 Participants |
| Region of Enrollment United States | 50 participants |
| Sex: Female, Male Female | 22 Participants |
| Sex: Female, Male Male | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 50 |
| other Total, other adverse events | 18 / 50 |
| serious Total, serious adverse events | 2 / 50 |
Outcome results
Primary
Improvement in NOSE Score
Mean change in Nasal Obstruction Symptom Evaluation (NOSE) score from baseline to 26 weeks post-study procedure. Improvement (baseline score - 26-week score) is signified by a positive 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, 26 weeks
Population: Does not include subject lost-to-follow-up prior to the 26-week follow-up visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vivaer Stylus | Improvement in NOSE Score | 54.8 units on a scale | Standard Deviation 21.9 |
p-value: <0.0001t-test, 2 sided
Secondary
NOSE Responder Rate
Percent subjects who are responders to therapy; responder is defined as a treated subject who experiences at least a 15-point improvement in NOSE score from baseline to 26 weeks post treatment.
Time frame: Baseline, 26 weeks
Population: Does not include subject lost-to-follow-up prior to 26-week follow-up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vivaer Stylus | NOSE Responder Rate | 93.9 percentage of treated subjects |
p-value: <0.0001binomial test
Secondary
Percentage of Participants With Treatment-Related Adverse Events (Safety)
Characterization of the type and frequency of treatment-related adverse events reported during or following the study procedure, throughout the follow-up period.
Time frame: Baseline through 26 weeks
Population: All treated subjects
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vivaer Stylus | Percentage of Participants With Treatment-Related Adverse Events (Safety) | 20 percentage of subjects having an event |
Other Pre-specified
Subject-reported Pain Related to the Study Procedure, as Reported on 100mm Visual Analog Scale
Procedure-related pain as reported by the subject using a 100mm Visual Analog Scale (VAS), immediately post-procedure and at the 4-week follow-up visit. Higher scores indicate more severe pain. The Pain VAS is presented to the subject as a 100mm line anchored on each end by verbal descriptors: 0 = no pain and 100 = worse pain imaginable. The distance between 0 and the vertical mark made by the subject is measured and the result is expressed in millimeters.
Time frame: Immediately after study procedure, 4-weeks
Population: All treated subjects were asked to rate the pain level in each of their nostrils immediately following the treatment procedure and at the 4-week follow-up visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vivaer Stylus | Subject-reported Pain Related to the Study Procedure, as Reported on 100mm Visual Analog Scale | Post-Procedure, left nostril | 28.7 units on a scale | Standard Deviation 26 |
| Vivaer Stylus | Subject-reported Pain Related to the Study Procedure, as Reported on 100mm Visual Analog Scale | Post-Procedure, right nostril | 26.9 units on a scale | Standard Deviation 23.9 |
| Vivaer Stylus | Subject-reported Pain Related to the Study Procedure, as Reported on 100mm Visual Analog Scale | 4-week visit, left nostril | 8.9 units on a scale | Standard Deviation 16 |
| Vivaer Stylus | Subject-reported Pain Related to the Study Procedure, as Reported on 100mm Visual Analog Scale | 4-week visit, right nostril | 8.7 units on a scale | Standard Deviation 14.5 |
Other Pre-specified
Subject Satisfaction
Study-specific survey to assess patient satisfaction with the discomfort of the procedure and recovery period, as well as their perceived results. The survey included 5 questions related to tolerability of the procedure, ease of recovery, change in breathing, satisfaction with treatment, and willingness to recommend treatment. Each question was scored on a 10-point scale, with 1 indicating the most negative response to the question (e.g., very bad, much worse, or very dissatisfied) and 10 indicating the most favorable rating (e.g., hardly noticeable, much better, or very satisfied). Each question was individually scored and reported.
Time frame: 26 weeks
Population: Does not include subject lost-to-follow-up prior to 26-week follow-up visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vivaer Stylus | Subject Satisfaction | Q1 - Procedure tolerability | 7.3 units on a scale | Standard Deviation 2.4 |
| Vivaer Stylus | Subject Satisfaction | Q2 - Ease of recovery | 8.3 units on a scale | Standard Deviation 1.7 |
| Vivaer Stylus | Subject Satisfaction | Q3 - Breathing through nose | 8.3 units on a scale | Standard Deviation 1.8 |
| Vivaer Stylus | Subject Satisfaction | Q4 - Satisfaction with treatment | 8.4 units on a scale | Standard Deviation 2.1 |
| Vivaer Stylus | Subject Satisfaction | Q5 - Likely to recommend to others | 8.7 units on a scale | Standard Deviation 2.1 |