Evaluation of the ClariFix™ Cryotherapy Device in Subjects With Chronic Rhinitis (FROST)

Clinical Evaluation of Safety and Efficacy for the ClariFix™ Cryotherapy Device in Subjects With Chronic Rhinitis

A multi-center, prospective, non-randomized, interventional clinical trial to assess the safety and effectiveness of the ClariFix™ 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 Device

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • East Palo Alto, California, United States, 94303
      • California Sleep Institute
    • Sacramento, California, United States, 95661
      • Sacramento Ear, Nose, and Throat
    • San Francisco, California, United States, 94108
      • San Francisco Otolaryngology Medical Group
  • Florida
    • Boca Raton, Florida, United States, 33487
      • Ear, Nose, and Throat Associates of South Florida
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18017
      • Bethlehem Ear, Nose, and Throat
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • EVMS Otolaryngology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Subject is >21 years of age
2. Subject has moderate to severe symptoms of rhinorrhea (individual symptom rating of 2 or 3), mild to severe symptoms of congestion (individual symptom rating of 1, 2 or 3) and a minimum TNSS score of 4 (out of 12) at the time of the treatment visit, which have been present for > 6 months.
3. Subject has had documented allergy test within the last 10 years that defines whether or not subject has allergies to perennial and seasonal allergens or is willing to have one performed prior to study exit.
4. Subject has been dissatisfied with medical management, defined as usage of intranasal steroids for a minimum of 4 weeks without adequate symptom relief by the subject's assessment.
5. Subject has signed IRB-approved informed consent form

Exclusion Criteria:

1. Subject has clinically significant anatomic obstructions that in the investigator's opinion limit access to the posterior nose, including but not limited to septal deviation or perforation, nasal polyps, sinonasal tumor.
2. Subject has had any prior sinus or nasal surgery that significantly alters the anatomy of the posterior nose.
3. Subject has active nasal or sinus infection.
4. Subject has moderate to severe ocular symptoms.
5. Subject has a history of nosebleeds in the past 3 months.
6. Subject has a history of rhinitis medicamentosa.
7. Subject has had prior head or neck irradiation
8. Subject has active coagulation disorder or is receiving anti-coagulants which cannot be safely stopped for 4 weeks (excluding aspirin).
9. Subject is pregnant.
10. Subject is participating in another clinical research study.
11. Subject has an allergy or intolerance to anesthetic agent.
12. Subject has cryoglobulinemia, paroxysmal cold hemoglobinuria, cold urticaria, Raynaud's disease, and/or, open and/or infected wounds at or near the target tissue.
13. Any physical condition that in the investigator's opinion would prevent adequate study participation or pose increased risk.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment with the ClariFix Device; Bilateral ablation of nasal tissue for treatment of chronic rhinitis	Device: ClariFix Device; Cryoablation in the nasal passageway using the ClariFix Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Symptom Severity	Effectiveness will be assessed by the mean change in nasal symptoms using the 4-symptom rTNSS (reflective Total Nasal Symptom Score). The rTNSS is the sum of 4 individual patient-rated symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, each evaluated using a scale of 0=None, 1=Mild, 2=Moderate, and 3=Severe. The rTNSS has a possible score of 0-12. The reflective scores are based on the participant's evaluation of symptom severity over the preceding 24 hours. A change of 1 or more is considered the minimum clinically important difference.	90 days post treatment
Device- and/or Procedure-related Serious Adverse Events	Safety will be evaluated based on the frequency of device- and/or procedure-related serious adverse events	90 days post treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)	The RQLQ is a validated quality of life questionnaire that evaluates functional problems associated with rhinitis. The questionnaire assess 7 domains: activities, sleep, nose symptoms, eye symptoms, non nose/eye symptoms, practical problems, and emotional function. Each question is scores on a 7-point scale (0=not impaired at all, 6=severely impaired). A domain and total scores are based on the mean of all answered items in that domain resulting in domain or total scores ranging from 0 to 6. An average change on 0.5 or more is considered a minimal clinically important difference.	90 days post treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Symptom Severity	Median change in nasal symptoms using the 4-symptom rTNSS (reflective Total Nasal Symptom Score). The rTNSS is the sum of 4 individual patient-rated symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, each evaluated using a scale of 0=None, 1=Mild, 2=Moderate, and 3=Severe. The rTNSS has a possible score of 0-12. The reflective scores are based on the participant's evaluation of symptom severity over the preceding 24 hours. A change of 1 point or more is considered the minimum clinically important difference.	1, 3, 6, 9, 12, 15, 18, 21, and 24 months post procedure

Collaborators and Investigators

• Sponsor: Arrinex, Inc.

Publications and helpful links

General Publications

• Chang MT, Song S, Hwang PH. Cryosurgical ablation for treatment of rhinitis: A prospective multicenter study. Laryngoscope. 2020 Aug;130(8):1877-1884. doi: 10.1002/lary.28301. Epub 2019 Sep 30.
• Ow RA, O'Malley EM, Han JK, Lam KK, Yen DM. Cryosurgical Ablation for Treatment of Rhinitis: Two-Year Results of a Prospective Multicenter Study. Laryngoscope. 2021 Sep;131(9):1952-1957. doi: 10.1002/lary.29453. Epub 2021 Feb 22.

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2017
• Primary Completion (Actual): July 31, 2018
• Study Completion (Actual): April 6, 2020

Study Registration Dates

• First Submitted: June 7, 2017
• First Submitted That Met QC Criteria: June 7, 2017
• First Posted (Actual): June 9, 2017

Study Record Updates

• Last Update Posted (Actual): March 17, 2021
• Last Update Submitted That Met QC Criteria: February 25, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Cryoablation; Cryotherapy
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Nose Diseases; Rhinitis
• Other Study ID Numbers: CT-0003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

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