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Evaluation of the Aerin Medical Device used for the treatment of nasal obstruction.
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.
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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 |
|---|---|---|
| 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. | Baseline, 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 26 weeks |
| Percentage of Participants With Treatment-Related Adverse Events (Safety) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Scott Wolf, MD | Aerin Medical | Study Director |
| Ofer Jacobowitz, MD, PhD | Mount Sinai Hospital, New York, NY | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central California Clinical Research | Fresno | California | 93720 | United States | ||
| Colorado ENT and Allergy |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| 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 | 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. | Does not include subject lost-to-follow-up prior to the 26-week follow-up visit | Posted | Mean | Standard Deviation | units on a scale | Baseline, 26 weeks |
|
From procedure through 26-week follow-up visit
All subjects were queried for adverse events after the procedure and at each follow-up visit. Details of events were documented on a standardized case report form. Anticipated observations in the treatment area (such as swelling, redness, or crusting related to the treatment of tissue with radiofrequency energy) were not considered adverse events unless they required mitigation or were greater in severity, duration or degree of incidence than expected.
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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 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment | unrelated to device or procedure |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nasopharyngitis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Scott Wolf, M.D., Chief Medical Officer | Aerin Medical, Inc. | 650-597-0111 | swolf@aerinmedical.com |
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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 | Feb 1, 2017 | Jan 3, 2018 | 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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Characterization of the type and frequency of treatment-related adverse events reported during or following the study procedure, throughout the follow-up period. |
| Baseline through 26 weeks |
| Immediately after study procedure, 4-weeks |
| 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. | 26 weeks |
| Colorado Springs |
| Colorado |
| 80909 |
| United States |
| ENT and Allergy Associates, LLP | Oradell | New Jersey | 07649 | United States |
| ENT and Allergy Associates, LLP | Bayside | New York | 11360 | United States |
| ENT and Allergy Associates, LLP | New Hyde Park | New York | 11042 | United States |
| ENT and Allergy Associates, LLP | New York | New York | 10017 | United States |
| ENT and Allergy Associates, LLP | Staten Island | New York | 10314 | United States |
| Piedmont Ear, Nose and Throat Associates | Winston-Salem | North Carolina | 27103 | United States |
| Ear, Nose and Throat Associates of Texas | McKinney | Texas | 75070 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | 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 | units on a scale |
|
|
|
|
| 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. | Does not include subject lost-to-follow-up prior to 26-week follow-up | Posted | Number | 95% Confidence Interval | percentage of treated subjects | Baseline, 26 weeks |
|
|
|
|
| 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. | All treated subjects | Posted | Number | percentage of subjects having an event | Baseline through 26 weeks |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Immediately after study procedure, 4-weeks | Nostrils | Nostrils |
|
|
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| 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. | Does not include subject lost-to-follow-up prior to 26-week follow-up visit | Posted | Mean | Standard Deviation | units on a scale | 26 weeks |
|
|
|
| 0 |
| 50 |
| 2 |
| 50 |
| 18 |
| 50 |
|
| Balance disorder | Nervous system disorders | MedDRA (14.1) | Systematic Assessment | Recurrence of multiple sclerosis symptoms; unrelated to device or procedure |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Nasal edema | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Sinusitis | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Rhinalgia | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
|
First publication of study results shall be made in conjunction with the results from all clinical study centers participating in the multicenter study. If results of the multi-center study have not been published in full within 18 months after completion of the study, investigator shall be free to publish results. Investigator agrees to submit all proposed publications to the sponsor at least 60 days prior submission; the company has the right to comment.
| D012120 |
| Respiration Disorders |
| D010038 | Otorhinolaryngologic Diseases |
| Post-Procedure, right nostril |
|
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| 4-week visit, left nostril |
|
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| 4-week visit, right nostril |
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| Title | Measurements |
|---|---|
|
| Q4 - Satisfaction with treatment |
|
| Q5 - Likely to recommend to others |
|