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Post-market study to continue to evaluate the effectiveness of the RhinAer Stylus for chronic rhinitis and the effect of treatment on inflammatory biomarkers.
Prospective, Open Label, Multicenter Study of the Aerin Medical RhinAer® Stylus for Chronic Rhinitis to continue to evaluate the effectiveness of the RhinAer® Stylus for treating the posterior nasal nerve area to improve symptoms in adults diagnosed with chronic rhinitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RhinAer Stylus treatment | Experimental | The RhinAer procedure will be performed in the study clinic using the RhinAer Stylus and Aerin Console. The RhinAer Stylus is a disposable handheld device capable of delivering bipolar radiofrequency energy to tissue when connected to the Aerin Console radiofrequency generating device. Participants will have both nostrils treated in the portion of the nasal cavity mucosa overlying the region of the posterior nasal nerve. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RhinAer Stylus | Device | The RhinAer procedure incorporates use of the RhinAer Stylus (Model FG1393, CAT1394), which is a 510(k) cleared (FDA - K221907) disposable handheld device capable of delivering bipolar radiofrequency energy to tissue. The Aerin Console (Model FG226) RF generator with temperature control capable of delivering very low doses of energy is also cleared for use in the US (FDA - K162810). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in expression of nasal mucosal inflammatory markers in allergic and nonallergic chronic rhinitis patients | Change from baseline in expression of type-2 inflammatory cytokine markers in nasal mucus samples at 3 months post-procedure | Baseline and 3 months post study procedure |
| Measure | Description | Time Frame |
|---|---|---|
| The change in cough and post-nasal drip symptoms | Change from baseline in cough and postnasal drip symptoms at 3 and 6 months post-procedure | From baseline to 6 months post-procedure |
| The change in nasal symptoms of chronic rhinitis |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the occurrence of any device- or procedure-related adverse events | Incidence, type, category, and severity of adverse events reported from time of consent through study completion, an average of 6 months. | From baseline to completion of study, an average of 6 months |
Inclusion Criteria:
Age 22 to 85 years (inclusively).
Willing and able to provide informed consent.
Willing and able to comply with the patient-specific requirements outlined in the study protocol.
Presenting to the ENT office seeking evaluation and/or treatment for chronic rhinitis (allergic or nonallergic) of at least 12 months duration
Willing to undergo the RhinAer procedure
Has a baseline rTNSS symptom score of ≥6 at time of screening
If on anticoagulation therapy, anticoagulant medications can be withheld during the perioperative period (at least 3-day window pre- and post-procedure).
Has been diagnosed with either allergic or non-allergic chronic rhinitis and meet the following criteria:
OR
-b. Nonallergic rhinitis: diagnosed with nonallergic rhinitis with demonstration of a negative skin prick testing, specific IgE blood testing, or other allergy testing methods, confirming the nonallergic nature of their rhinitis within the past 24 months.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Colorado ENT & Allergy | Colorado Springs | Colorado | 80923 | United States | ||
| University of Cincinnati |
No data collected will be shared with other researchers participating in the study.
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| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D003139 | Common Cold |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
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Active treatment for all subject enrolling prospectively.
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|
Change from baseline in Reflective Total Nasal Symptom Score (rTNSS) total score at 3 and 6 months post-procedure. This is a 4 item questionnaire and each is scored from 0 (none) to 3 (severe), with a maximum score of 12. A higher number indicating more congestion.
| From baseline to 6 months post-procedure |
| Change in SNOT-22 score | Change from baseline in Sino-nasal Outcome Test (SNOT-22) score at 3 and 6 months post-procedure. The SNOT-22 contains 22 nose, sinus, and general health-related quality of life (HRQoL) items and is used to measure HRQoL associated with rhinosinusitis. Participants are required to indicate the level to which each listed nasal, sinus or HRQoL experience has been affected on a 6-point scale ranging from 0 (No problem) to 5 (Problem as bad as it can be). | From baseline to 6 months post-procedure |
| Evaluate the impact of the RhinAer treatment in subjects with migraine-related symptoms | Change from baseline in Headache Impact Test (HIT-6) score at 3 and 6 months post-procedure. The HIT-6 is an instrument used to measure the adverse impact of headache on social functioning, role functioning, vitality, cognitive functioning and psychological distress as well as severity of headache pain. The HIT-6 requires patients to answer six questions regarding their migraines, each question is scored on a 5-point Likert scale. The HIT-6 scores range from 36 to 78. Higher scores indicate a greater impact of headaches on the respondent's life, i.e., Little or no impact (46 or less), Some impact (50 -55), Substantial impact (56-59) or Severe impact (60-78). | From baseline to 6 months post-procedure |
| Evaluate medication usage in chronic rhinitis patients | Change from baseline in medication usage at 3 months and 6 months post-procedure. Self-reported assessments of any change from baseline in frequency (including those taken as needed), dose, or change in route of administration of medications used to manage nasal symptoms related to chronic rhinitis, will be recorded. Assessment of medication use will be repeated at the time of procedure and at all subsequent follow-up timepoints, through completion of the study, an average of 6 months. | From baseline to completion of study, an average of 6 months |
| Evaluate patient reported pain outcomes related to the study procedure | VAS will be completed by the patient immediately post-procedure. The Visual Analogue Scale (VAS) is a unidimensional measure of pain intensity that will be used to measure nasal pain associated with the procedure. A VAS is a 100-mm long horizontal line with verbal descriptors (word anchors) at each end to express the extremes of the feeling. Scores are obtained by measuring the distance in millimeters from the left origin of the line (0) to the point indicated with a slash placed by the patient to indicate their current level of pain in and around the nose. Results are then assigned a score between 0 and 100. | Completed following the study procedure during treatment visit |
| Cincinnati |
| Ohio |
| 45267 |
| United States |
| D010038 |
| Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |