Multi-Treatment PNN Modulation for Chronic Rhinitis

Study Overview
=================
Brief Summary
-----------------
Feasibility of treatment at multiple sites with the ClariFix cryoablation device for treatment of chronic rhinitis

Official Title
-----------------
Feasibility Study of Multi-Treatment Posterior Nasal Nerve (PNN) Modulation for Treatment of Chronic Rhinitis

Conditions
-----------------
Chronic Rhinitis

Intervention / Treatment
-----------------
* Device: ClariFix


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Presence of moderate to severe rhinorrhea symptoms and mild to severe nasal congestion symptoms for >3 months. Documented allergy test within the last 10 years that defines whether or not subject has allergies to perennial and seasonal allergens, or is willing to have one performed prior to study exit. Able to provide informed consent and willing to complete study activities and visits per protocol. Exclusion Criteria: Clinically significant anatomic obstructions that limit access to the posterior nose. Prior sinus or nasal surgery that significantly alters the anatomy of the posterior nose. Moderate to severe ocular symptoms as determined. History of epistaxis in the past 3 months. History of rhinitis medicamentosa. Prior head or neck irradiation. Active or chronic nasal or sinus infection. Pregnant. Allergy or intolerance to anesthetic agent. Cryoglobulinemia, paroxysmal cold hemoglobinuria, cold urticaria, Raynaud's disease, and/or, open and/or infected wounds at or near the target tissue. Currently participating in another clinical research study. Any physical condition that, in the investigator's opinion, would prevent adequate study participation or pose increased risk.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective, non-randomized, feasibility study of multi-treatment locations
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active Treatment<br>Cryotherapy of the posterior nasal nerve using the ClariFix device | Device: ClariFix<br>* The ClariFix™ device (K162608) is an FDA 510(k) cleared Class II cryosurgical tool indicated for the destruction of unwanted tissue during surgical procedures, including in adults with chronic rhinitis.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Procedure-related Serious Adverse Events (SAEs) and/or Serious Adverse Device Effects (SADE) | The outcome measure is the number of participants experiencing 1 or more SAEs/SADEs. | Study duration (90-days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Scores | Tolerability of treatment as provided by the participant by verbal report of pain/discomfort during treatment and post treatment using an 11-point scale indicating pain intensity from 0 (no pain) to 10 (worst pain). | Day of treatment during procedure and for up to 1 hour post procedure | 
| Change From Baseline in the Reflective Total Nasal Symptom Score (rTNSS) | The rTNSS is a validated patient-reported outcome measure consisting of 4 symptoms: rhinorrhea, nasal congestion, nasal itching, and sneezing. Each item is scored on a scale of 0 (no symptoms) to 3 (severe symptoms). The total rTNSS is the sum of the 4 symptom scores and has a possible range of 0 to 12 points. The change from baseline is calculated as the follow-up value minus the baseline value. Negative values indicate improved symptoms. | 30 and 90 days after treatment | 
| Change From Baseline in the Overall Nasal Obstruction Symptom Evaluation (NOSE) Score | The NOSE survey is a patient-reported outcome measure consisting of 5 nasal symptoms: nasal congestion or stuffiness, nasal blockage or obstruction, trouble breathing through the nose, trouble sleeping, and unable to get enough air through the nose during exercise or exertion. Each symptom is scored using a 5-point scale of 0 (not a problem) to 4 (severe problem). The 5 symptom scores are summed and the total is multiplied by 5 to give a total score that ranges from 0 to 100, with higher scores indicating worse symptoms. The change from baseline is calculated as the follow-up value minus the baseline value. Negative values indicate improved symptoms. | 30 and 90 days after treatment |