Registry of Subject Treated With ClariFix
- Conditions
- Chronic Rhinitis
- Registration Number
- NCT03739216
- Lead Sponsor
- Arrinex, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 354
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from baseline in nasal symptom severity Follow-up visits at 6 weeks, 3, 6, 9, 12, 15, 18, 21, and 24 months post treatment 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.
- Secondary Outcome Measures
Name Time Method Patient-assessed improvement in nasal symptoms Follow-up visits at 6 weeks, 3, 6, 9, 12, 15, 18, 21, and 24 months post treatment 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).
Clinician-assessed improvement in nasal symptoms Follow-up visit at 3 months post treatment 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).
Trial Locations
- Locations (22)
Del Rey Allergy & Sinus
🇺🇸Marina Del Rey, California, United States
Sacramento, Ear, Nose, and Throat
🇺🇸Roseville, California, United States
UC Davis Dept of Otolaryngology
🇺🇸Sacramento, California, United States
Breathe Clear Institutue
🇺🇸Torrance, California, United States
Light ENT
🇺🇸Boynton Beach, Florida, United States
Ear, Nose, and Throat Associates of South Florida
🇺🇸Plantation, Florida, United States
North Georgia ENT
🇺🇸Cumming, Georgia, United States
Chicago Nasal & Sinus
🇺🇸Chicago, Illinois, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Tandem Clinical Research
🇺🇸Marrero, Louisiana, United States
Scroll for more (12 remaining)Del Rey Allergy & Sinus🇺🇸Marina Del Rey, California, United States