A Prospective, Multi-Center Registry of Subjects Treated With the ClariFix Cryotherapy Device

Arrinex, Inc.22 sites in 1 country354 target enrollmentJune 13, 2018

ConditionsChronic Rhinitis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Chronic Rhinitis
Sponsor: Arrinex, Inc.
Enrollment: 354
Locations: 22
Primary Endpoint: Change from baseline in nasal symptom severity
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 13, 2018

End Date

June 15, 2021

Last Updated

4 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Arrinex, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Change from baseline in nasal symptom severity

Time Frame: 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 Outcomes

Patient-assessed improvement in nasal symptoms(Follow-up visits at 6 weeks, 3, 6, 9, 12, 15, 18, 21, and 24 months post treatment)
Clinician-assessed improvement in nasal symptoms(Follow-up visit at 3 months post treatment)