Registry of Subject Treated With ClariFix

Study Overview
=================
Brief Summary
-----------------
A multi-center, prospective, non-randomized, observational registry to asses the results of the ClariFix(TM) device when used to ablate unwanted tissue in the nose of subjects with chronic rhinitis.

Official Title
-----------------
A Prospective, Multi-Center Registry of Subjects Treated With the ClariFix Cryotherapy Device

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

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participant is scheduled to receive treatment with the ClariFix device in accordance with the ClariFix Instructions for Use. Participant is able to provide consent and willing to adhere to the study visit schedule. Exclusion Criteria: Participant is scheduled to have additional treatment and/or procedures completed at the same time of treatment with the ClariFix device. Participant is scheduled to have additional nasal or sinus treatments and/or procedures completed within 3 months of treatment with the ClariFix device.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Open label<br>Open label registry study of patients treated with the ClariFix device for chronic rhinitis. | Device: ClariFix<br>* The ClariFix device is a handheld cryosurgical device which provides focal, controlled freezing to the target tissue.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in nasal symptom severity | Effectiveness will be assessed by the change from baseline in nasal symptoms using the TNSS (Total Nasal Symptom Score). The TNSS is a patient-reported assessment of 4 symptom scores for rhinorrhea (runny nose), nasal congestion, nasal itching, and sneezing. Each symptom is rated on a scale of 0 (none) to 3 (severe). The symptom scores are summed to give a total TNSS score that can range from 0 to 12. | Follow-up visits at 6 weeks, 3, 6, 9, 12, 15, 18, 21, and 24 months post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-assessed improvement in nasal symptoms | Percentage of participants reporting their change from baseline as minimally improved, much improved, or very much improved using the Patient Global Impression of Change (PGIC) assessment. The PGIC has patients evaluate their improvement over baseline on a scale from 1 (very much improved) to 7 (very much worse). | Follow-up visits at 6 weeks, 3, 6, 9, 12, 15, 18, 21, and 24 months post treatment | 
| Clinician-assessed improvement in nasal symptoms | Percentage of clinicians reporting their participants change in nasal symptoms from baseline as minimally improved, much improved, or very much improved using the Clinical Global Impression - Improvement (CGI-I) assessment. The CGI-I has clinicians rate their patient's improvement over baseline on a scale from 1 (very much improved) to 7 (very much worse). | Follow-up visit at 3 months post treatment |