ClariFix Cryoablation Clinical Study

Study Overview
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Brief Summary
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This is a single-arm pilot study designed to evaluate the feasibility of cryoablation in the nasal passageway, using the ClariFix device, to reduce the symptoms of chronic rhinitis.

Detailed Description
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This is a small, prospective, multicenter, single-arm, self-controlled interventional feasibility study to evaluation cryoablation in the nasal passage as a treatment for chronic rhinitis. The ClariFix device is FDA-cleared device with the intended use for the destruction of unwanted tissue during surgical procedures, including in adults with chronic rhinitis.

Official Title
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Clinical Evaluation of Cryotherapy in the Nasal Passageway Using the ClariFix Device

Conditions
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Rhinitis

Intervention / Treatment
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* Device: ClariFix device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is >21 years of age Subject has had moderate to severe symptoms of rhinorrhea and/or nasal congestion for >3 months (rTNSS rating of 2 or 3) Subject has signed IRB-approved informed consent form Exclusion Criteria: Subject has clinically significant anatomic obstructions that limit access to the posterior nose including severe septal deviation, nasal polyps, and sinonasal tumor Subject has a septal perforation Subject has had prior sinus or nasal surgery that significantly alters the anatomy of the posterior nose Subject has had prior head or neck irradiation Subject has active or chronic nasal or sinus infection Subject has active coagulation disorder or patient is receiving anti-coagulants which cannot be safely stopped for 2 weeks Subject has a history of dry nose symptoms Subject is pregnant or lactating Subject is participating in another clinical research study Subject has an allergy or intolerance to anesthetic agent Subject is an active smoker or has been a smoker within the last 6 months Any physical condition that in the investigator's opinion would prevent adequate study participation or pose increased risk

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Cryoablation with the ClariFix device | Device: ClariFix device<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device- and/or Procedure-related Serious Adverse Events | Number of participants with device- and/or procedure-related serious adverse events reported over the initial study follow-up period. | Baseline through 365 days post treatment | 
| Change in Rhinitis Symptom Severity (rTNSS) | Change from baseline in participant-reported symptom severity based on the rTNSS (Reflective Total Nasal Symptom Score). The rTNSS is the sum of 4 individual subject-assessed symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, each evaluated using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe. The rTNSS has a possible score range of 0-12. The reflective scores are based on the participant's evaluation of symptom severity over the preceding 12 hours. | Baseline through 365 days post treatment | 
| Change in Rhinitis Symptoms (VAS) | Change from baseline in rhinitis symptoms measured on a participant-reported visual analog scale (VAS). Symptoms of rhinorrhea, nasal breathing, facial pain/pressure, and sense of smell were rated from 0 (no symptoms) to 10 (severe/extremely bothersome symptoms) assessed over the 12 hours preceding the visit. An average of the 4 individual scores was used as the total VAS score with a range of 0 to 10. | Baseline through 365 days post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ease of Use | Physician evaluation of ClariFix ease of use. After each participant's treatment, the physician was asked to rate the ClariFix on ease of use. Options were easy, moderately easy, moderately difficult, or difficult. | Immediately post treatment | 
| Device- and/or Procedure-related Adverse Events | All adverse events evaluated as possibly, probably, or definitely related to the ClariFix device and/or procedure. | Baseline through 90 days post treatment |