Clinical Evaluation of Safety and Efficacy for the ClariFix™ Cryotherapy Device in Subjects With Chronic Rhinitis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Rhinitis
- Sponsor
- Arrinex, Inc.
- Enrollment
- 100
- Locations
- 6
- Primary Endpoint
- Device- and/or Procedure-related Serious Adverse Events
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
A multi-center, prospective, non-randomized, interventional clinical trial to assess the safety and effectiveness of the ClariFix™ device when used to ablate unwanted tissue in the nose of subjects with chronic rhinitis.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subject is \>21 years of age
- •Subject has moderate to severe symptoms of rhinorrhea (individual symptom rating of 2 or 3), mild to severe symptoms of congestion (individual symptom rating of 1, 2 or 3) and a minimum TNSS score of 4 (out of 12) at the time of the treatment visit, which have been present for \> 6 months.
- •Subject has had 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.
- •Subject has been dissatisfied with medical management, defined as usage of intranasal steroids for a minimum of 4 weeks without adequate symptom relief by the subject's assessment.
- •Subject has signed IRB-approved informed consent form
Exclusion Criteria
- •Subject has clinically significant anatomic obstructions that in the investigator's opinion limit access to the posterior nose, including but not limited to septal deviation or perforation, nasal polyps, sinonasal tumor.
- •Subject has had any prior sinus or nasal surgery that significantly alters the anatomy of the posterior nose.
- •Subject has active nasal or sinus infection.
- •Subject has moderate to severe ocular symptoms.
- •Subject has a history of nosebleeds in the past 3 months.
- •Subject has a history of rhinitis medicamentosa.
- •Subject has had prior head or neck irradiation
- •Subject has active coagulation disorder or is receiving anti-coagulants which cannot be safely stopped for 4 weeks (excluding aspirin).
- •Subject is pregnant.
- •Subject is participating in another clinical research study.
Outcomes
Primary Outcomes
Device- and/or Procedure-related Serious Adverse Events
Time Frame: 90 days post treatment
Safety will be evaluated based on the frequency of device- and/or procedure-related serious adverse events
Change From Baseline in Symptom Severity
Time Frame: 90 days post treatment
Effectiveness will be assessed by the mean change in nasal symptoms using the 4-symptom rTNSS (reflective Total Nasal Symptom Score). The rTNSS is the sum of 4 individual patient-rated symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, each evaluated using a scale of 0=None, 1=Mild, 2=Moderate, and 3=Severe. The rTNSS has a possible score of 0-12. The reflective scores are based on the participant's evaluation of symptom severity over the preceding 24 hours. A change of 1 or more is considered the minimum clinically important difference.
Secondary Outcomes
- Change From Baseline in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)(90 days post treatment)