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Post-market study to continue to evaluate the effectiveness of the Vivaer® ARC Stylus for nasal airway obstruction
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vivaer Stylus | Experimental | Intervention: Procedure: thermal treatment of submucosal tissue including cartilage in the internal nasal valve area |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vivaer Stylus | Device | Delivery of low-power, temperature-controlled, radiofrequency energy to the tissues of the internal nasal valve area |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 Month |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Age 18 or older
Willing and able to provide informed consent
Willing and able to comply with the study protocol
Seeking treatment for nasal obstruction
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):
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alabama Nasal and Sinus Center | Birmingham | Alabama | 35242 | United States | ||
| Arizona Desert ENT Specialists |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37621275 | Result | Yao WC, Pritikin J, Sillers MJ, Barham HP. Two-year outcomes of temperature-controlled radiofrequency device treatment of the nasal valve for patients with nasal airway obstruction. Laryngoscope Investig Otolaryngol. 2023 Jun 15;8(4):808-815. doi: 10.1002/lio2.1089. eCollection 2023 Aug. | |
| Result | Yao WC, Ow RA, Barham HP (2021) Temperature-Controlled Radiofrequency Treatment of the Nasal Valve and Nasal Airway Obstruction: Early Results of a Prospective, Multi-Center Study. J Otolaryngol Rhinol 7:104. doi.org/10.23937/2572-4193.1510105 | ||
| 40196218 |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Vivaer Treatment | Single Arm Study. Eligible subjects who have signed consent and qualify will have their nasal valve treated in a single Vivaer® treatment session and will be considered enrolled once the device has entered the nasal cavity. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| 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 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. | Posted | Mean | Standard Error | score on a scale | 3 Month |
|
|
2 years
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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 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Events Leading to Death | Infections and infestations | Non-systematic Assessment | COVID-19 |
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Limitations of this study are its lack of a control arm and the non-blinded nature of this study
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Operations | Aerin Medical | 650-518-9624 | alaborde@aerinmedical.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 16, 2022 | Jan 27, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 8, 2022 | Jan 27, 2023 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 21, 2022 | Jan 27, 2023 | ICF_002.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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| 3 months post study procedure |
| 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 | 24 Month |
| 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 | 24 Months |
| Goodyear |
| Arizona |
| 85395 |
| United States |
| Sacramento ENT | Roseville | California | 95661 | United States |
| ENT Associates of South Florida | Boca Raton | Florida | 33487 | United States |
| ENT Associates of South Florida | Plantation | Florida | 33324 | United States |
| Chicago Nasal and Sinus Center | Chicago | Illinois | 60602 | United States |
| Baton Rouge General / Sinus and Nasal Specialists of Louisiana | Baton Rouge | Louisiana | 70809 | United States |
| Advocare Aroesty ENT Associates | Mount Arlington | New Jersey | 07856 | United States |
| UT Physicians Otorhinolaryngology - Texas Medical Center | Houston | Texas | 77030 | United States |
| ENT Associates of Texas | McKinney | Texas | 75070 | United States |
| Result |
| Yao WC, Ow R, Sillers MJ, Nachlas NE, Johnson CD, Ehmer D, Pritikin J, Barham HP. Three-Year Outcomes After Temperature-Controlled Radiofrequency Treatment of Nasal Airway Obstruction. OTO Open. 2025 Apr 7;9(2):e70111. doi: 10.1002/oto2.70111. eCollection 2025 Apr-Jun. |
| Withdrawal by Subject |
|
| Death due to COVID-19 |
|
| Data missing for full evaluation |
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Baseline NOSE Scale Score | Nasal Obstruction Symptom Evaluation Scale (NOSE scale). Subject completed 1 month review of the following 5 categories: Nasal Congestion/Stuffiness; Nasal Blockage or Obstruction; Trouble Breathing through my nose; Trouble Sleeping/ Unable to get enough air through my nose during exercise or exertion. Subjects answer 0-4 (0=not a problem; 1=very mild problem; 2=moderate problem; 3fairly bad problem; 4=severe problem) answers are multiplied by 5, score is out of 100 | Mean | Standard Deviation | units on a scale |
|
| Body Mass Index | Average Body Mass Index across all subjects | Mean | Standard Deviation | Kg/m^2 |
|
| Nasal Valve Collapse Mechanism | Count of Participants | Participants |
|
| Additional Nasal Obstruction Diagnosis | Count of Participants | Participants |
|
| History of Nasal Surgery | Count of Participants | 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. | All treated subjects VAS score at 3 months post procedure | Posted | Mean | Standard Deviation | millimeters | 3 months post study procedure |
|
|
|
| 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 | Posted | Count of Participants | Participants | 24 Month |
|
|
|
| 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 | A total of 1010 patients reached 2 year follow-up, of which, 12 had an additional nasal procedure and were reviewed separately | Posted | Mean | Standard Error | score on a scale | 24 Months |
|
|
|
| 1 |
| 122 |
| 1 |
| 122 |
| 0 |
| 122 |
|
| Abdominal Pain | Gastrointestinal disorders | Non-systematic Assessment | Severe Abdominal Pain |
|
| Corneal Damage | Eye disorders | Non-systematic Assessment |
|
| Worsening Nasal Airway Obstruction | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Psychiatric Disorder | Psychiatric disorders | Non-systematic Assessment |
|
| Ankle Break | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| pulmonary Alveolar Protenosis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Prostate Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Carpal Tunnel Syndrome | Nervous system disorders | Non-systematic Assessment |
|
| Aortic Stenosis | Cardiac disorders | Non-systematic Assessment |
|
| Ischemic Attack | Nervous system disorders | Non-systematic Assessment |
|
| Urinary Tract Infection | Renal and urinary disorders | Non-systematic Assessment |
|
| Hypertension | Cardiac disorders | Non-systematic Assessment |
|
| Upper Respiratory Infection | Infections and infestations | Non-systematic Assessment |
|
| Acute Kidney Injury | Renal and urinary disorders | Non-systematic Assessment |
|
| Bacteremia | Infections and infestations | Non-systematic Assessment |
|
| Iron Deficiency Anemia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Hyponatremia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
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| D012120 |
| Respiration Disorders |
| D010038 | Otorhinolaryngologic Diseases |