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| Name | Class |
|---|---|
| Ohio State University | OTHER |
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This study evaluates subjective and objective measures of treatment outcome after using the Aerin Medical Vivaer™ Stylus to treat nasal obstruction
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vivaer Stylus Treatment | Experimental | Thermal treatment of the submucosal tissue including cartilage in the internal nasal valve area |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vivaer Stylus | Device | Stylus used to deliver low-power, temperature-controlled, radiofrequency energy to the tissues of the internal nasal valve area |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 90 days |
| 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. | Baseline, 90 days |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Peak Nasal Inspiratory Flow | Peak inspiratory flow measurements of nasal physical resistance | Baseline, 90 days |
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):
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brad Otto, MD | The Ohio State Eye and Ear Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State Eye and Ear Institute | Columbus | Ohio | 43212 | United States |
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Patients with a history of chronic nasal obstruction for at least 1 year were prospectively enrolled at this tertiary academic center.
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| ID | Title | Description |
|---|---|---|
| FG000 | Vivaer Stylus Treatment | Thermal treatment of the submucosal tissue including cartilage in the internal nasal valve area Vivaer Stylus: Stylus used to deliver low-power, temperature-controlled, radiofrequency energy to the tissues of the internal nasal valve area |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Includes all subjects treated with the Vivaer Stylus who were evaluated 90 days post-treatment
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| ID | Title | Description |
|---|---|---|
| BG000 | Subjects Followed Through 90 Days | Patient cohort includes all subjects treated with the Vivaer Stylus who were evaluated 90 days post-treatment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 90 days |
|
From procedure through 90-day evaluation
Subjects were queried for adverse events after the procedure and at the 90-day evaluation visit. Details of events were documented on a standardized case report form.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Subjects Followed Through 90 Days | Patient cohort includes all subjects treated with the Vivaer Stylus who were evaluated 90 days post-treatment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Orthopedic injury or surgery | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kai Zhao, PhD. | Dept. of Otolaryngology-Head and Neck Surgery, The Ohio State University | 614-293-3857 | zhao.1949@osu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 25, 2019 | May 16, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015508 | Nasal Obstruction |
| ID | Term |
|---|---|
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D000402 | Airway Obstruction |
| D012131 | Respiratory Insufficiency |
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|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Nasal Obstruction Symptom Evaluation (NOSE) score | 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. | Mean | Standard Deviation | score on a scale |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| 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. | Includes all subjects treated with the Vivaer Stylus who were evaluated 90 days post-treatment | Posted | Mean | Standard Deviation | units on a scale | Baseline, 90 days |
|
|
|
| Other Pre-specified | Change in Peak Nasal Inspiratory Flow | Peak inspiratory flow measurements of nasal physical resistance | Posted | Mean | Standard Deviation | ml/sec | Baseline, 90 days |
|
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| 6 |
| 18 |
| Sinusitis | Infections and infestations | Systematic Assessment |
|
| Dental treatments | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Body rash | Infections and infestations | Systematic Assessment |
|
| Colonoscopy with polyp removal | General disorders | Systematic Assessment |
|
| Bulb on nostril with diminished airflow | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
PI/Institution will provide Sponsor with a copy of any proposed manuscripts or other material for publication thirty (30) days prior to publication for review and comment. Sponsor's comments shall be given due consideration by PI/Institution. Publication may be delayed at Sponsor's written request for a period not to exceed sixty (60) days if it contains a disclosure of an invention(s) on which either party desires to file a patent.
| D012120 |
| Respiration Disorders |
| D010038 | Otorhinolaryngologic Diseases |