A Study of RhinAer ARC Stylus for Treating Chronic Rhinitis (RELIEF)

Study Overview
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Brief Summary
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Post-market study to continue to evaluate the effectiveness of the RhinAer ARC Stylus for chronic rhinitis.

Detailed Description
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Prospective, Open Label, Multicenter Study of the Aerin Medical RhinAer® ARC Stylus for Chronic Rhinitis to continue to evaluate the effectiveness of the RhinAer® ARC Stylus for treating the posterior nasal nerve area to improve symptoms in adults diagnosed with chronic rhinitis.

Official Title
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A Prospective, Open Label, Multi-Center Study Using the RhinAer Procedure for Treatment of Subjects Suffering With Chronic Rhinitis

Conditions
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Chronic Rhinitis

Intervention / Treatment
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* Device: RhinAer ARC Stylus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 to 85 years (inclusively). Willing and able to provide informed consent. Willing and able to comply with the subject-specific requirements outlined in the Study Protocol. Seeking treatment for chronic rhinitis symptoms of at least 6 months duration and willing to undergo an office-based procedure. Moderate to severe symptoms of rhinorrhea (rTNSS rating of 2 or 3 for rhinorrhea). Mild to severe symptoms of nasal congestion (rTNSS rating of 1, 2 or 3 for congestion). rTNSS ≥ 6. Exclusion Criteria: Anatomic obstructions that in the investigator's opinion limit access to the posterior nasal passage. Altered anatomy of the posterior nose as a result of prior sinus or nasal surgery or injury. Active nasal or sinus infection. History of significant dry eye. History of any of the following: chronic epistaxis, documented episodes of significant nose bleeds in the past 3 months, rhinitis medicamentosa, head or neck irradiation. Have rhinitis symptoms only on a seasonal basis due to allergies. Known or suspected allergies or contraindications to the anesthetic agents and/or antibiotic medications to be used during the study procedure session. Known or suspected to be pregnant or is lactating. Participating in another clinical research study. Has any condition that predisposes to excessive bleeding. Is taking anticoagulants (eg, warfarin, Plavix) or 325 mg aspirin that cannot be discontinued before the procedure. Has previous procedure or surgery for chronic rhinitis. Other medical conditions which in the opinion of the investigator would predispose the subject to poor wound healing, increased surgical risk, or poor compliance with the requirements of the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Active treatment for all subject enrolling prospectively
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RhinAer ARC Stylus Treatment<br>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. | Device: RhinAer ARC Stylus<br>* The RhinAer procedure incorporates use of the RhinAer Stylus (Model FG815), which is a cleared (FDA - K192471) disposable handheld device capable of delivering bipolar radiofrequency energy to tissue. RhinAer has CE Marking in EU. The Aerin Console (Model FG226) RF generator with temperature control capable of delivering very low doses of energy was cleared for use in the US (FDA - K162810) and has CE Marking in the EU (CE639608).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change of the Reflective Total Nasal Symptoms Score (rTNSS) | The TNSS is an instrument used to collect patient self-rated severity of nasal symptoms originally comprised of 3 symptoms (nasal obstruction, itching/sneezing and secretion/runny nose) that has been widely adapted to include 4 nasal symptoms: rhinorrhea, nasal congestion, nasal itching, and sneezing. The patient rates 4 nasal symptoms (rhinorrhea, nasal congestion, nasal itching and sneezing) on the following 4-point scale: 0 = absent symptoms (no sign/symptom is evident) 1 = mild symptoms (sign/symptom present, but minimal awareness; easily tolerated) 2 = moderate symptoms (definite awareness of sign/symptom that is bothersome but tolerable) 3 = severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping). The total score is the sum of the 4 nasal symptoms. A low score indicates lower symptoms, a higher score indicates more symptoms. | Baseline and 3 months post study procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30% Improvement in Reflective Total Nasal Symptoms Score (rTNSS) | The TNSS is an instrument used to collect patient self-rated severity of nasal symptoms. The patient rates 4 nasal symptoms (rhinorrhea, nasal congestion, nasal itching and sneezing) on the following 4-point scale: 0 = absent symptoms (no sign/symptom is evident) 1 = mild symptoms (sign/symptom present, but minimal awareness; easily tolerated) 2 = moderate symptoms (definite awareness of sign/symptom that is bothersome but tolerable) 3 = severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping). The total score is the sum of the 4 nasal symptoms. A low score indicates lower symptoms, a higher score indicates more symptoms. Improvement indicates if the score at 3 months is lower than at Baseline. | Baseline and 3 months post study procedure | 
| Mean Change in Mini Rhinoconjuctivitis Quality of Life Questionnaire (RQLQ) | The Rhinoconjuctivitis Quality of Life Questionnaire is a well-established, validated, and the most frequently used rhinoconjuctivitis disease-specific instrument. The MiniRQLQ, to be used in this study, was developed and validated to further facilitate ease of use and efficiency by reducing the number of questions to 14. The instrument consists of 14 questions across 5 domains (activity limitations (n=3), practical problems (n=2), nose symptoms (n=3), eye symptoms (n=3), and other symptoms (n=3)). Responses are based on a 1-week recall and provided on a 7-point scale: 0 = not troubled 1 = hardly troubled at all 2 = somewhat troubled 3 = moderately troubled 4 = quite a bit troubled 5 = very troubled 6 = extremely troubled. The total or overall MiniRQLQ score is the mean of the 14 responses and the domain scores are the mean of the questions in each domain. | Baseline and 3 months post study procedure | 
| Device Related Adverse Events | Evaluate profile by characterizing the type and frequency of adverse events reported at or following the study procedure an throughout the follow up period | Baseline and 3 months post study procedure |