Posterior Nasal Nerve (PNN) Rhinitis Study

Study Overview
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Brief Summary
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Evaluation of the Aerin Medical Device used for the treatment of chronic rhinitis

Detailed Description
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This is a non-significant risk, prospective, multi-center, non-randomized study to evaluate the safety and efficacy of the Aerin Medical device (InSeca Stylus) when used to deliver radiofrequency (RF) energy to the posterior nasal nerve area to improve symptoms in those diagnosed with chronic rhinitis.

Official Title
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Clinical Evaluation of Low Power Radiofrequency Energy Applied to the Posterior Nasal Nerve Area for Symptomatic Relief of Chronic Rhinitis

Conditions
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Chronic Rhinitis

Intervention / Treatment
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* Device: InSeca Stylus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 22 to 75 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 score of greater than or equal to 6 Dissatisfaction with medical management, defined as usage of intranasal steroids for a minimum of 4 weeks without adequate symptom relief, as judged by the subject Exclusion Criteria: Anatomic obstructions that in the investigator's opinion limit access to the posterior nose Altered anatomy of the posterior nose as a result of prior sinus or nasal surgery or injury Active nasal or sinus infection Moderate to severe ocular allergic symptoms (such as eye tearing [epiphora], itching [pruritus], or redness [erythema]) History of significant dry eye History of any of the following: nose bleeds in the past 3 months, rhinitis medicamentosa, head or neck irradiation 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 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: 22 Years
Maximum Age: 75 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: All enrolled subjects will be treated with the InSeca Stylus
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: InSeca Stylus Treatment Group<br>Subjects treated with low power radiofrequency energy applied to the nasal cavity mucosa overlying the region of the posterior nasal nerve (the posterior middle meatus and posterior inferior meatus) | Device: InSeca Stylus<br>* Low power radiofrequency energy delivery to the portion of the nasal cavity mucosa overlying the region of the posterior nasal nerve (the posterior middle meatus and posterior inferior meatus).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Reflective Total Nasal Symptom Score (rTNSS) | Mean change in Reflective Total Nasal Symptoms Score (rTNSS) from baseline to 12 weeks post-study procedure. Improvement (12 week score - baseline score) is signified by a negative value. 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 the rTNSS total score from Baseline to 12 week follow up visit | Comparison of scores at Baseline and 12 weeks post procedure | 
| 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. Subjects were asked about possible side effects or adverse experiences related to the study procedure at each follow up visit. Each event was documented and identified as to its relationship and level of relatedness to the study device and/or study procedure. This measure includes any subject who experienced at least one event considered definitely, probably, or possibly related to the device or procedure. | At or following the study procedure, and up to the final study visit at 1 year. |