RhinAer Procedure for Treatment of Chronic Rhinitis Study

Study Overview
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Brief Summary
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The purpose of this study is to compare the RhinAer procedure with radiofrequency (RF) energy to sham procedure for treatment of chronic rhinitis.

Detailed Description
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The purpose of this study is to compare the RhinAer procedure to treat tissue in the posterior nasal nerve area to improve symptoms in adults diagnosed with chronic rhinitis with a sham procedure that duplicates the actual procedure as closely as possible absent the delivery of radiofrequency (RF) energy to the nasal tissue.

Official Title
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The RhinAer Procedure for Treatment of CHronic RhInitis - A Prospective, MulticeNter Randomized ConTrolled TRial Comparing RhinAer to Sham Control (RHINTRAC)

Conditions
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Chronic Rhinitis

Intervention / Treatment
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* Device: RhinAer Stylus
* Device: Sham


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
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: 2:1 site-stratified randomization will be used to allocate participants to either the RhinAer procedure or treatment with the sham (control) procedure. Crossover within 30 days after 3- or 6-month follow-up visit.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: RhinAer 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 the portion of the nasal cavity mucosa overlying the region of the posterior nasal nerve (the posterior middle meatus and posterior inferior turbinate) in both nostrils treated during a single study procedure session. Each nostril will be treated at 1, 2, 3, 4 or 5 nonoverlapping positions depending on the size of the target treatment area. Treatment settings to be used are temperature 60 °C, power 4 watts, treatment time 12 seconds, and cooling time 0 seconds | Device: RhinAer Stylus<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 the portion of the nasal cavity mucosa overlying the region of the posterior nasal nerve (the posterior middle meatus and posterior inferior turbinate) in both nostrils treated during a single study procedure session.<br>|
| Sham Comparator: Control Treatment<br>The control treatment will be performed in the study clinic using the RhinAer Stylus while audible sounds that accurately simulate the Aerin Console's active treatment are produced even though RF energy is not being generated or delivered. All other aspects of the procedure will be the same as used for the active treatment, including administration of anesthetic agent(s). | Device: Sham<br>* The control treatment will be performed in the study clinic using the RhinAer Stylus while audible sounds that accurately simulate the Aerin Console's active treatment are produced even though RF energy is not being generated or delivered. All other aspects of the procedure will be the same as used for the active treatment, including administration of anesthetic agent(s).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reflective Total Nasal Symptom Score (rTNSS) Responder Rate | TNSS is an instrument used to collect patient self-rated severity of nasal symptoms. 4 Symptoms (rhinorrhea, nasal congestion, nasal itching and sneezing) are reported with score of 0/absent; 1/mild; 2/moderate; 3/severe. The total score is the sum of the 4 nasal symptom scores with a maximum TNSS of 12 indicating the most severe symptoms. Treatment Responder based on rTNSS improvement Individual participant success (responder) is defined as at least 30% improvement (decrease) in the rTNSS from baseline. For this protocol patients had to meet inclusion criteria of rTNSS rating of 2 or 3 for Rhinorrhea; rTNSS rating of 1, 2 or 3 for Congestion; and total rTNSS score >/= 6 at baseline | 3 months visit following the study procedure. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reflective Total Nasal Symptom Score (rTNSS) Mean Change | The Reflective Total Nasal Symptom Score (rTNSS) is a patient self reported questionnaire of four nasal symptoms: rhinitis, nasal congestion, nasal itching and sneezing. Patients will report their symptoms reflected or felt over the last 12 hours. Total scores can range from 0 to 12. A higher score indicates increased symptom severity. This study will measure the mean change in rTNSS from baseline to 3 months after the procedure. | Change from Baseline to 3 months following the study procedure. | 
| Percentage of Participants With Treatment Related Events (Safety) | Characterizing the type and frequency of adverse events reported. Subjects will be asked about possible side effects or adverse experiences related to the study procedure at each follow up visit. All events will be documented and identified as to its relationship and level of relatedness to the study device and/or study procedure. Date of onset, severity, duration and outcome will be documented. | At or following the study procedure up to to 3 months. |