ClariFix Cryoablation Clinical Study

Not Applicable

Completed

Brief Summary: 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: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Intervention	ClariFix device	Cryoablation with the ClariFix device

Primary Outcome Measures

Name	Time	Method
Device- and/or Procedure-related Serious Adverse Events	Baseline through 365 days post treatment	Number of participants with device- and/or procedure-related serious adverse events reported over the initial study follow-up period.
Change in Rhinitis Symptom Severity (rTNSS)	Baseline through 365 days post treatment	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.
Change in Rhinitis Symptoms (VAS)	Baseline through 365 days post treatment	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.

Secondary Outcome Measures

Name	Time	Method
Device- and/or Procedure-related Adverse Events	Baseline through 90 days post treatment	All adverse events evaluated as possibly, probably, or definitely related to the ClariFix device and/or procedure.
Ease of Use	Immediately post treatment	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.