Back to resultsEvaluation of the ClariFix™ Cryotherapy Device in Subjects With Chronic Rhinitis (FROST)
Primary Purpose
Chronic Rhinitis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ClariFix Device
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Rhinitis focused on measuring Cryotherapy, Cryoablation
Eligibility Criteria
Inclusion Criteria:
- Subject is >21 years of age
- 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.
- 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.
- 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.
- Subject has signed IRB-approved informed consent form
Exclusion Criteria:
- 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.
- Subject has had any prior sinus or nasal surgery that significantly alters the anatomy of the posterior nose.
- Subject has active nasal or sinus infection.
- Subject has moderate to severe ocular symptoms.
- Subject has a history of nosebleeds in the past 3 months.
- Subject has a history of rhinitis medicamentosa.
- Subject has had prior head or neck irradiation
- Subject has active coagulation disorder or is receiving anti-coagulants which cannot be safely stopped for 4 weeks (excluding aspirin).
- Subject is pregnant.
- Subject is participating in another clinical research study.
- Subject has an allergy or intolerance to anesthetic agent.
- Subject has cryoglobulinemia, paroxysmal cold hemoglobinuria, cold urticaria, Raynaud's disease, and/or, open and/or infected wounds at or near the target tissue.
- Any physical condition that in the investigator's opinion would prevent adequate study participation or pose increased risk.
Sites / Locations
- California Sleep Institute
- Sacramento Ear, Nose, and Throat
- San Francisco Otolaryngology Medical Group
- Ear, Nose, and Throat Associates of South Florida
- Bethlehem Ear, Nose, and Throat
- EVMS Otolaryngology
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment with the ClariFix Device
Arm Description
Bilateral ablation of nasal tissue for treatment of chronic rhinitis
Outcomes
Primary Outcome Measures
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.
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
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03181594
Brief Title
Evaluation of the ClariFix™ Cryotherapy Device in Subjects With Chronic Rhinitis
Acronym
FROST
Official Title
Clinical Evaluation of Safety and Efficacy for the ClariFix™ Cryotherapy Device in Subjects With Chronic Rhinitis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
March 2, 2017 (Actual)
Primary Completion Date
July 31, 2018 (Actual)
Study Completion Date
April 6, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arrinex, Inc.
4. Oversight
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
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Rhinitis
Keywords
Cryotherapy, Cryoablation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment with the ClariFix Device
Arm Type
Experimental
Arm Description
Bilateral ablation of nasal tissue for treatment of chronic rhinitis
Intervention Type
Device
Intervention Name(s)
ClariFix Device
Intervention Description
Cryoablation in the nasal passageway using the ClariFix Device
Primary Outcome Measure Information:
Title
Change From Baseline in Symptom Severity
Description
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.
Time Frame
90 days post treatment
Title
Device- and/or Procedure-related Serious Adverse Events
Description
Safety will be evaluated based on the frequency of device- and/or procedure-related serious adverse events
Time Frame
90 days post treatment
Secondary Outcome Measure Information:
Title
Change From Baseline in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)
Description
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.
Time Frame
90 days post treatment
Other Pre-specified Outcome Measures:
Title
Change From Baseline in Symptom Severity
Description
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.
Time Frame
1, 3, 6, 9, 12, 15, 18, 21, and 24 months post procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject is >21 years of age
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.
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.
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.
Subject has signed IRB-approved informed consent form
Exclusion Criteria:
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.
Subject has had any prior sinus or nasal surgery that significantly alters the anatomy of the posterior nose.
Subject has active nasal or sinus infection.
Subject has moderate to severe ocular symptoms.
Subject has a history of nosebleeds in the past 3 months.
Subject has a history of rhinitis medicamentosa.
Subject has had prior head or neck irradiation
Subject has active coagulation disorder or is receiving anti-coagulants which cannot be safely stopped for 4 weeks (excluding aspirin).
Subject is pregnant.
Subject is participating in another clinical research study.
Subject has an allergy or intolerance to anesthetic agent.
Subject has cryoglobulinemia, paroxysmal cold hemoglobinuria, cold urticaria, Raynaud's disease, and/or, open and/or infected wounds at or near the target tissue.
Any physical condition that in the investigator's opinion would prevent adequate study participation or pose increased risk.
Facility Information:
Facility Name
California Sleep Institute
City
East Palo Alto
State/Province
California
ZIP/Postal Code
94303
Country
United States
Facility Name
Sacramento Ear, Nose, and Throat
City
Sacramento
State/Province
California
ZIP/Postal Code
95661
Country
United States
Facility Name
San Francisco Otolaryngology Medical Group
City
San Francisco
State/Province
California
ZIP/Postal Code
94108
Country
United States
Facility Name
Ear, Nose, and Throat Associates of South Florida
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33487
Country
United States
Facility Name
Bethlehem Ear, Nose, and Throat
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18017
Country
United States
Facility Name
EVMS Otolaryngology
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31566744
Citation
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.
Results Reference
result
PubMed Identifier
33616224
Citation
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.
Results Reference
result
Learn more about this trial
Evaluation of the ClariFix™ Cryotherapy Device in Subjects With Chronic Rhinitis
We'll reach out to this number within 24 hrs