Rhinitis
Conditions
Brief summary
This is a single-arm pilot study designed to evaluate the feasibility of cryoablation in the nasal passageway, using the ClariFix device, to reduce the symptoms of chronic rhinitis.
Detailed description
This is a small, prospective, multicenter, single-arm, self-controlled interventional feasibility study to evaluation cryoablation in the nasal passage as a treatment for chronic rhinitis. The ClariFix device is FDA-cleared device with the intended use for the destruction of unwanted tissue during surgical procedures, including in adults with chronic rhinitis.
Interventions
DEVICEClariFix 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 had moderate to severe symptoms of rhinorrhea and/or nasal congestion for \>3 months (rTNSS rating of 2 or 3) 3. Subject has signed IRB-approved informed consent form
Exclusion criteria
1. Subject has clinically significant anatomic obstructions that limit access to the posterior nose including severe septal deviation, nasal polyps, and sinonasal tumor 2. Subject has a septal perforation 3. Subject has had prior sinus or nasal surgery that significantly alters the anatomy of the posterior nose 4. Subject has had prior head or neck irradiation 5. Subject has active or chronic nasal or sinus infection 6. Subject has active coagulation disorder or patient is receiving anti-coagulants which cannot be safely stopped for 2 weeks 7. Subject has a history of dry nose symptoms 8. Subject is pregnant or lactating 9. Subject is participating in another clinical research study 10. Subject has an allergy or intolerance to anesthetic agent 11. Subject is an active smoker or has been a smoker within the last 6 months 12. 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 |
|---|---|---|
| Device- and/or Procedure-related Serious Adverse Events | Baseline through 365 days post treatment | Number of participants with device- and/or procedure-related serious adverse events reported over the initial study follow-up period. |
| Change in Rhinitis Symptom Severity (rTNSS) | Baseline through 365 days post treatment | Change from baseline in participant-reported symptom severity based on the rTNSS (Reflective Total Nasal Symptom Score). The rTNSS is the sum of 4 individual subject-assessed symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, each evaluated using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe. The rTNSS has a possible score range of 0-12. The reflective scores are based on the participant's evaluation of symptom severity over the preceding 12 hours. |
| Change in Rhinitis Symptoms (VAS) | Baseline through 365 days post treatment | Change from baseline in rhinitis symptoms measured on a participant-reported visual analog scale (VAS). Symptoms of rhinorrhea, nasal breathing, facial pain/pressure, and sense of smell were rated from 0 (no symptoms) to 10 (severe/extremely bothersome symptoms) assessed over the 12 hours preceding the visit. An average of the 4 individual scores was used as the total VAS score with a range of 0 to 10. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ease of Use | Immediately post treatment | Physician evaluation of ClariFix ease of use. After each participant's treatment, the physician was asked to rate the ClariFix on ease of use. Options were easy, moderately easy, moderately difficult, or difficult. |
| Device- and/or Procedure-related Adverse Events | Baseline through 90 days post treatment | All adverse events evaluated as possibly, probably, or definitely related to the ClariFix device and/or procedure. |
Participant flow
Recruitment details
27 participants were enrolled and treated with bilateral cryotherapy of the nasal passage (54 treatments).
Participants by arm
| Arm | Count |
|---|---|
| Intervention Treatment with the ClariFix Device
ClariFix Device | 27 |
| Total | 27 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 12 |
Baseline characteristics
| Characteristic | Intervention |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 7 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants |
| Age, Continuous | 53.29 Years |
| Region of Enrollment United States | 27 participants |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 27 |
| other Total, other adverse events | 19 / 27 |
| serious Total, serious adverse events | 0 / 27 |
Outcome results
Primary
Change in Rhinitis Symptom Severity (rTNSS)
Change from baseline in participant-reported symptom severity based on the rTNSS (Reflective Total Nasal Symptom Score). The rTNSS is the sum of 4 individual subject-assessed symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, each evaluated using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe. The rTNSS has a possible score range of 0-12. The reflective scores are based on the participant's evaluation of symptom severity over the preceding 12 hours.
Time frame: Baseline through 365 days post treatment
Population: All participants with follow-up at the indicated visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Change in Rhinitis Symptom Severity (rTNSS) | 7 Days post treatment | -1.9 score on a scale | Standard Deviation 0.6 |
| Intervention | Change in Rhinitis Symptom Severity (rTNSS) | 30 Days post treatment | -3.6 score on a scale | Standard Deviation 0.6 |
| Intervention | Change in Rhinitis Symptom Severity (rTNSS) | 90 Days post treatment | -3.3 score on a scale | Standard Deviation 0.6 |
| Intervention | Change in Rhinitis Symptom Severity (rTNSS) | 180 Days post treatment | -4.0 score on a scale | Standard Deviation 0.5 |
| Intervention | Change in Rhinitis Symptom Severity (rTNSS) | 365 Days post treatment | -4.5 score on a scale | Standard Deviation 0.3 |
Comparison: Null hypothesis is that the within-participant change from baseline in rTNSS is 0.p-value: <0.001t-test, 2 sided
Primary
Change in Rhinitis Symptoms (VAS)
Change from baseline in rhinitis symptoms measured on a participant-reported visual analog scale (VAS). Symptoms of rhinorrhea, nasal breathing, facial pain/pressure, and sense of smell were rated from 0 (no symptoms) to 10 (severe/extremely bothersome symptoms) assessed over the 12 hours preceding the visit. An average of the 4 individual scores was used as the total VAS score with a range of 0 to 10.
Time frame: Baseline through 365 days post treatment
Population: All treated participants with follow-up at the indicated visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Change in Rhinitis Symptoms (VAS) | 7 Days post treatment | -2.1 score on a scale | Standard Deviation 0.5 |
| Intervention | Change in Rhinitis Symptoms (VAS) | 30 Days post treatment | -3.8 score on a scale | Standard Deviation 0.5 |
| Intervention | Change in Rhinitis Symptoms (VAS) | 90 Days post treatment | -4.1 score on a scale | Standard Deviation 0.6 |
| Intervention | Change in Rhinitis Symptoms (VAS) | 180 Days post treatment | -2.9 score on a scale | Standard Deviation 0.7 |
| Intervention | Change in Rhinitis Symptoms (VAS) | 365 Days post treatment | -5.6 score on a scale | Standard Deviation 1.1 |
Comparison: Null hypothesis is that the within-participant change from baseline in rhinitis symptoms VAS is 0.p-value: <0.001t-test, 2 sided
Primary
Device- and/or Procedure-related Serious Adverse Events
Number of participants with device- and/or procedure-related serious adverse events reported over the initial study follow-up period.
Time frame: Baseline through 365 days post treatment
Population: A total of 27 subjects were enrolled and received bilateral cryosurgery with the ClariFix device (n=54 treatments).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention | Device- and/or Procedure-related Serious Adverse Events | 0 participants |
Secondary
Device- and/or Procedure-related Adverse Events
All adverse events evaluated as possibly, probably, or definitely related to the ClariFix device and/or procedure.
Time frame: Baseline through 90 days post treatment
Population: All treated participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | Device- and/or Procedure-related Adverse Events | 1 Participants |
Secondary
Ease of Use
Physician evaluation of ClariFix ease of use. After each participant's treatment, the physician was asked to rate the ClariFix on ease of use. Options were easy, moderately easy, moderately difficult, or difficult.
Time frame: Immediately post treatment
Population: Physician evaluation of ease of use after each ClariFix procedure.
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Intervention | Ease of Use | Easy | 14 Procedures |
| Intervention | Ease of Use | Moderately easy | 10 Procedures |
| Intervention | Ease of Use | Moderately difficult | 3 Procedures |
| Intervention | Ease of Use | Difficult | 0 Procedures |