An observational study in Chronic Rhinitis, sponsored by Arrinex, Inc.. Completed at 23 sites in United States. Per ClinicalTrials.gov, last updated 2021-08-03.
Sponsored by Arrinex, Inc. · Observational
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.
1,105 studies on the registry are indexed under Rhinitis; 65 are open to participants now.
This study's enrollment of 354 is above the median of 141 across 172 observational studies indexed under Rhinitis.
Browse Rhinitis studies →Arrinex, Inc. is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Physicians and staff will invite patients receiving treatment with ClariFix device and who meet enrollment criteria to participate in the registry. Invited patients who provide informed consent will be enrolled into the registry. Baseline, treatment, and follow-up data will be collected at predetermined intervals.
Exclusion Criteria:
Open label registry study of patients treated with the ClariFix device for chronic rhinitis.
Device: ClariFix
The ClariFix device is a handheld cryosurgical device which provides focal, controlled freezing to the target tissue.
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.
Time frame: Follow-up visits at 6 weeks, 3, 6, 9, 12, 15, 18, 21, and 24 months post treatment
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).
Time frame: 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).
Time frame: Follow-up visit at 3 months post treatment
This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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Arrinex, Inc.