Chronic Rhinitis
Conditions
Keywords
Cryotherapy, Cryoablation
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.
Interventions
DEVICEClariFix Device
Cryoablation in the nasal passageway using the ClariFix Device
Sponsors
Arrinex, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Symptom Severity | 90 days post treatment | 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 | 90 days post treatment | Safety will be evaluated based on the frequency of device- and/or procedure-related serious adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) | 90 days post treatment | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Symptom Severity | 1, 3, 6, 9, 12, 15, 18, 21, and 24 months post procedure | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment With the ClariFix Device Bilateral ablation of nasal tissue for treatment of chronic rhinitis
ClariFix Device: Cryoablation in the nasal passageway using the ClariFix Device | 100 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Initial Study Protocol (12-month FU) | Death | 1 |
| Initial Study Protocol (12-month FU) | Lost to Follow-up | 4 |
| Initial Study Protocol (12-month FU) | Physician Decision | 1 |
| Initial Study Protocol (12-month FU) | Withdrawal by Subject | 3 |
| Long-term Extension (15-24 Month FU) | Death | 2 |
| Long-term Extension (15-24 Month FU) | Lost to Follow-up | 3 |
Baseline characteristics
| Characteristic | Treatment With the ClariFix Device |
|---|---|
| Age, Continuous | 58.8 years STANDARD_DEVIATION 16.2 |
| Baseline rTNSS | 6.14 units on a scale STANDARD_DEVIATION 1.87 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 96 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants |
| Race (NIH/OMB) White | 90 Participants |
| Region of Enrollment United States | 100 participants |
| Rhinitis subtype Allergic | 30 Participants |
| Rhinitis subtype Non-allergic | 70 Participants |
| Sex: Female, Male Female | 64 Participants |
| Sex: Female, Male Male | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 4 / 100 |
| other Total, other adverse events | 0 / 100 |
| serious Total, serious adverse events | 9 / 100 |
Outcome results
Primary
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.
Time frame: 90 days post treatment
Population: All treated participants with 90-day follow-up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment With the ClariFix Device | Change From Baseline in Symptom Severity | -3.1 score on a scale | Standard Deviation 2.6 |
Comparison: The null hypothesis was that the mean change from baseline for the rTNSS would be 0 (no effect). Assumptions included an alpha level of 0.5 (2-tailed), 90% power, and a standard deviation of 2.5 for the mean change from baseline. A total of 68 participants was deemed adequate to test the hypothesis.p-value: <0.001t-test, 2 sided
Primary
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
Time frame: 90 days post treatment
Population: All treated participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment With the ClariFix Device | Device- and/or Procedure-related Serious Adverse Events | 1 events |
Secondary
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.
Time frame: 90 days post treatment
Population: All treated participants with 90-day follow-up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment With the ClariFix Device | Change From Baseline in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) | -1.5 score on a scale | Standard Deviation 1.2 |
p-value: <0.001t-test, 2 sided
Other Pre-specified
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.
Time frame: 1, 3, 6, 9, 12, 15, 18, 21, and 24 months post procedure
Population: All participants with rTNSS scores.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Treatment With the ClariFix Device | Change From Baseline in Symptom Severity | 1-month | -3.0 score on a scale |
| Treatment With the ClariFix Device | Change From Baseline in Symptom Severity | 3-month | -3.0 score on a scale |
| Treatment With the ClariFix Device | Change From Baseline in Symptom Severity | 6-month | -3.0 score on a scale |
| Treatment With the ClariFix Device | Change From Baseline in Symptom Severity | 9-month | -3.0 score on a scale |
| Treatment With the ClariFix Device | Change From Baseline in Symptom Severity | 12-month | -3.0 score on a scale |
| Treatment With the ClariFix Device | Change From Baseline in Symptom Severity | 15-month | -4.0 score on a scale |
| Treatment With the ClariFix Device | Change From Baseline in Symptom Severity | 18-month | -3.0 score on a scale |
| Treatment With the ClariFix Device | Change From Baseline in Symptom Severity | 21-month | -4.0 score on a scale |
| Treatment With the ClariFix Device | Change From Baseline in Symptom Severity | 24-month | -4.0 score on a scale |
p-value: <0.001Wilcoxon signed rank