Chronic Rhinitis
Conditions
Brief summary
Feasibility of treatment at multiple sites with the ClariFix cryoablation device for treatment of chronic rhinitis
Interventions
DEVICEClariFix
The ClariFix™ device (K162608) is an FDA 510(k) cleared Class II cryosurgical tool indicated for the destruction of unwanted tissue during surgical procedures, including in adults with chronic rhinitis.
Sponsors
Arrinex, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, non-randomized, feasibility study of multi-treatment locations
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Presence of moderate to severe rhinorrhea symptoms and mild to severe nasal congestion symptoms for \>3 months. * 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. * Able to provide informed consent and willing to complete study activities and visits per protocol.
Exclusion criteria
* Clinically significant anatomic obstructions that limit access to the posterior nose. * Prior sinus or nasal surgery that significantly alters the anatomy of the posterior nose. * Moderate to severe ocular symptoms as determined. * History of epistaxis in the past 3 months. * History of rhinitis medicamentosa. * Prior head or neck irradiation. * Active or chronic nasal or sinus infection. * Pregnant. * Allergy or intolerance to anesthetic agent. * Cryoglobulinemia, paroxysmal cold hemoglobinuria, cold urticaria, Raynaud's disease, and/or, open and/or infected wounds at or near the target tissue. * Currently participating in another clinical research study. * 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 |
|---|---|---|
| Number of Participants With Procedure-related Serious Adverse Events (SAEs) and/or Serious Adverse Device Effects (SADE) | Study duration (90-days) | The outcome measure is the number of participants experiencing 1 or more SAEs/SADEs. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Scores | Day of treatment during procedure and for up to 1 hour post procedure | Tolerability of treatment as provided by the participant by verbal report of pain/discomfort during treatment and post treatment using an 11-point scale indicating pain intensity from 0 (no pain) to 10 (worst pain). |
| Change From Baseline in the Reflective Total Nasal Symptom Score (rTNSS) | 30 and 90 days after treatment | The rTNSS is a validated patient-reported outcome measure consisting of 4 symptoms: rhinorrhea, nasal congestion, nasal itching, and sneezing. Each item is scored on a scale of 0 (no symptoms) to 3 (severe symptoms). The total rTNSS is the sum of the 4 symptom scores and has a possible range of 0 to 12 points. The change from baseline is calculated as the follow-up value minus the baseline value. Negative values indicate improved symptoms. |
| Change From Baseline in the Overall Nasal Obstruction Symptom Evaluation (NOSE) Score | 30 and 90 days after treatment | The NOSE survey is a patient-reported outcome measure consisting of 5 nasal symptoms: nasal congestion or stuffiness, nasal blockage or obstruction, trouble breathing through the nose, trouble sleeping, and unable to get enough air through the nose during exercise or exertion. Each symptom is scored using a 5-point scale of 0 (not a problem) to 4 (severe problem). The 5 symptom scores are summed and the total is multiplied by 5 to give a total score that ranges from 0 to 100, with higher scores indicating worse symptoms. The change from baseline is calculated as the follow-up value minus the baseline value. Negative values indicate improved symptoms. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Active Treatment ClariFix: The ClariFix™ device (K162608) is an FDA 510(k) cleared Class II cryosurgical tool indicated for the destruction of unwanted tissue during surgical procedures, including in adults with chronic rhinitis. | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | Active Treatment |
|---|---|
| Age, Continuous | 60.0 years STANDARD_DEVIATION 15.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 28 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Number with allergic rhinitis | 11 Participants |
| Number with nonallergic rhinitis | 17 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 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 | 2 Participants |
| Race (NIH/OMB) White | 27 Participants |
| Region of Enrollment United States | 30 participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 22 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
Primary
Number of Participants With Procedure-related Serious Adverse Events (SAEs) and/or Serious Adverse Device Effects (SADE)
The outcome measure is the number of participants experiencing 1 or more SAEs/SADEs.
Time frame: Study duration (90-days)
Population: All enrolled participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Active Treatment | Number of Participants With Procedure-related Serious Adverse Events (SAEs) and/or Serious Adverse Device Effects (SADE) | 0 Participants |
Secondary
Change From Baseline in the Overall Nasal Obstruction Symptom Evaluation (NOSE) Score
The NOSE survey is a patient-reported outcome measure consisting of 5 nasal symptoms: nasal congestion or stuffiness, nasal blockage or obstruction, trouble breathing through the nose, trouble sleeping, and unable to get enough air through the nose during exercise or exertion. Each symptom is scored using a 5-point scale of 0 (not a problem) to 4 (severe problem). The 5 symptom scores are summed and the total is multiplied by 5 to give a total score that ranges from 0 to 100, with higher scores indicating worse symptoms. The change from baseline is calculated as the follow-up value minus the baseline value. Negative values indicate improved symptoms.
Time frame: 30 and 90 days after treatment
Population: All enrolled participants with the applicable follow-up visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active Treatment | Change From Baseline in the Overall Nasal Obstruction Symptom Evaluation (NOSE) Score | 30-day follow-up | -19.0 score on a scale | Standard Deviation 28.3 |
| Active Treatment | Change From Baseline in the Overall Nasal Obstruction Symptom Evaluation (NOSE) Score | 90-day follow-up | -31.4 score on a scale | Standard Deviation 34.4 |
p-value: <0.03t-test, 2 sided
Secondary
Change From Baseline in the Reflective Total Nasal Symptom Score (rTNSS)
The rTNSS is a validated patient-reported outcome measure consisting of 4 symptoms: rhinorrhea, nasal congestion, nasal itching, and sneezing. Each item is scored on a scale of 0 (no symptoms) to 3 (severe symptoms). The total rTNSS is the sum of the 4 symptom scores and has a possible range of 0 to 12 points. The change from baseline is calculated as the follow-up value minus the baseline value. Negative values indicate improved symptoms.
Time frame: 30 and 90 days after treatment
Population: All enrolled participants with the applicable follow-up visit.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Active Treatment | Change From Baseline in the Reflective Total Nasal Symptom Score (rTNSS) | 30-day follow-up | -3.5 score on a scale |
| Active Treatment | Change From Baseline in the Reflective Total Nasal Symptom Score (rTNSS) | 90-day follow-up | -4.0 score on a scale |
p-value: <0.0001Wilcoxon (Mann-Whitney)
Secondary
Pain Scores
Tolerability of treatment as provided by the participant by verbal report of pain/discomfort during treatment and post treatment using an 11-point scale indicating pain intensity from 0 (no pain) to 10 (worst pain).
Time frame: Day of treatment during procedure and for up to 1 hour post procedure
Population: All enrolled participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active Treatment | Pain Scores | Post treatment | 4.1 score on a scale | Standard Deviation 3.87 |
| Active Treatment | Pain Scores | During treatment | 1.0 score on a scale | Standard Deviation 1.95 |