Registry of Subject Treated With ClariFix

Arrinex, Inc.354 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

354

Conditions

Chronic Rhinitis

Interventions

ClariFixDEVICE

The ClariFix device is a handheld cryosurgical device which provides focal, controlled freezing to the target tissue.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (23)

Del Rey Allergy & Sinus

Bakersfield, California, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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