Registry of Subject Treated With ClariFix (SNIF)

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

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 Overview

• Status: Completed
• Conditions: Chronic Rhinitis
• Intervention / Treatment: Device: ClariFix

• Study Type: Observational
• Enrollment (Actual): 354

Contacts and Locations

Study Locations

• United States
  • California
    • Bakersfield, California, United States, 93312
      • Del Rey Allergy & Sinus
    • Marina Del Rey, California, United States, 90292
      • Del Rey Allergy & Sinus
    • Roseville, California, United States, 95661
      • Sacramento, Ear, Nose, and Throat
    • Sacramento, California, United States, 95817
      • UC Davis Dept of Otolaryngology
    • Torrance, California, United States, 90503
      • Breathe Clear Institutue
  • Florida
    • Boynton Beach, Florida, United States, 33426
      • Light ENT
    • Plantation, Florida, United States, 33324
      • Ear, Nose, and Throat Associates of South Florida
  • Georgia
    • Cumming, Georgia, United States, 30040
      • North Georgia ENT
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
    • Chicago, Illinois, United States, 60602
      • Chicago Nasal & Sinus
  • Louisiana
    • Marrero, Louisiana, United States, 70072
      • Tandem Clinical Research
  • New York
    • Albany, New York, United States, 12206
      • Albany ENT & Allergy
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mt. Sinai
    • New York, New York, United States, 10016
      • ENT & Allergy/Northwell Health
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27103
      • Piedmont ENT
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18017
      • Bethlehem ENT
  • Texas
    • Fort Worth, Texas, United States, 76104
      • Texas Healthcare
    • Frisco, Texas, United States, 75034
      • Collin County ENT
    • Houston, Texas, United States, 77030
      • UT Health
    • McKinney, Texas, United States, 75070
      • ENT Associates of Texas
  • Utah
    • Ogden, Utah, United States, 84403
      • Ogden Clinic
  • Virginia
    • Alexandria, Virginia, United States, 22310
      • Metropolitan ENT
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53215
      • Aurora Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Open label; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Follow-up visits at 6 weeks, 3, 6, 9, 12, 15, 18, 21, and 24 months post treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	Follow-up visit at 3 months post treatment

Collaborators and Investigators

• Sponsor: Arrinex, Inc.
• Investigators: Principal Investigator: Amber U Luong, MD, PhD, UT Health - The University of Texas

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2018
• Primary Completion (Actual): June 15, 2021
• Study Completion (Actual): June 15, 2021

Study Registration Dates

• First Submitted: October 3, 2018
• First Submitted That Met QC Criteria: November 9, 2018
• First Posted (Actual): November 13, 2018

Study Record Updates

• Last Update Posted (Actual): August 3, 2021
• Last Update Submitted That Met QC Criteria: July 28, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Nose Diseases; Rhinitis
• Other Study ID Numbers: CT-0004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No