Chronic Rhinitis
Conditions
Keywords
Cryotherapy, Cryoablation
Brief summary
A randomized, sham-controlled, single-blind study of cryotherapy as a treatment for chronic rhinitis.
Detailed description
A prospective, multicenter, randomized, sham-controlled, single-blind (participants) study to demonstrate the superiority of treatment with the ClariFix cryotherapy device for reducing symptoms when compared with a sham treatment in patients with chronic rhinitis. The ClariFix device is a Class II FDA-cleared medical device that is intended to be used as a cryosurgical tool for the destruction of unwanted tissue during surgical procedures, including in adults with chronic rhinitis.
Interventions
DEVICEClariFix cryotherapy
Bilateral freeze ablation of nasal tissue using the ClariFix device.
DEVICESham ClariFix cryotherapy
Bilateral sham ablation procedure using the ClariFix device.
Sponsors
North American Science Associates Inc.
Stryker Instruments
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
All participants will be blinded to treatment assignment from procedure through their 90-day visit.
Intervention model description
Participants will be randomized 1:1 to ClariFix or a sham procedure. After the 90-day visit, control participants may crossover to active ClariFix treatment, if they continue to meet enrollment criteria.
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Be ≥21 years of age. 2. Has been diagnosed with chronic nonallergic or allergic rhinitis. 3. Have moderate to severe symptoms of rhinorrhea (individual reflective Total Nasal Symptoms Score \[rTNSS\] symptom rating of 2 or 3), mild to severe symptoms of nasal congestion (individual rTNSS symptom rating of 1, 2, or 3), and a minimum total rTNSS of 4 (out of 12) at baseline. 4. Have an allergy test (by skin prick or intradermal testing or by validated in vitro tests for specific Immunoglobin E \[IgE\]) on file within 12 months of the baseline visit. 5. Be an appropriate candidate for bilateral ClariFix treatment performed under local anesthesia. 6. Be willing and able to comply with all study elements, as indicated by their written informed consent. 7. Be willing and able to comply with all study elements and provide written consent.
Exclusion criteria
1. Have clinically significant anatomic obstructions that in the investigator's opinion limit access to the posterior nose, including but not limited to severe septal deviation or perforation, nasal polyps, and/or sinonasal tumor. 2. Have had previous sinus or nasal surgery within 6 months of study enrollment. 3. Have previously undergone cryotherapy or other surgical interventions for rhinitis. 4. Have an active nasal or sinus infection. 5. Have rhinitis symptoms that are primarily due to seasonal allergies. 6. Have plans to (or otherwise anticipates the need to) undergo an ENT (ear, nose, throat) procedure concurrently or within 3 months after the study procedure. 7. Is on prescribed anticoagulants (eg, warfarin, Plavix) or 325 mg aspirin that cannot be discontinued before the procedure (81 mg aspirin and herbal supplements are acceptable). 8. Be unable to discontinue ipratropium bromide (IB) at least 14 days before baseline and through the 90-day follow-up visit. 9. Have a history of chronic epistaxis or experienced a significant epistaxis event (defined as epistaxis requiring medical intervention) in the past 3 months. 10. Have a history of rhinitis medicamentosa. 11. Have had previous head and/or neck irradiation. 12. Have an allergy or intolerance to local anesthetic agents. 13. Have cryoglobulinemia, paroxysmal cold hemoglobinuria, cold urticaria, Raynaud's disease, and/or open and/or infected wounds at or near the target tissue. 14. Have a neurological, medical, psychiatric condition, or social circumstance that would potentially increase risk, interfere with study participation, or confound interpretation of study data. 15. Be participating in another clinical research study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| rTNSS Responder Rate | 90-days post treatment | Responders are defined as participants with a 30% or greater reduction in reflective Total Nasal Symptom Score (rTNSS) relative to baseline. The active treatment will be compared with the sham treatment. The reflective Total Nasal Symptom Score (rTNSS) is a validated PRO consisting of 4 nasal symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing that are assessed over the previous 2-week period. Each symptom is rated on a scale of 0 (no symptoms) to 3 (severe symptoms) and the scores are summed to provide a total rTNSS with a possible range of 0 to 12. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| rTNSS Responder Rate | Through 12 months post treatment | Mean change from baseline in the rTNSS. The reflective Total Nasal Symptom Score (rTNSS) is a validated PRO consisting of 4 nasal symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing that are assessed over the previous 2-week period. Each symptom is rated on a scale of 0 (no symptoms) to 3 (severe symptoms) and the scores are summed to provide a total rTNSS with a possible range of 0 to 12. |
| Change in Total RQLQ(S) | Through 12 months post treatment | Mean change from baseline in the Standardized Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ(S)) score. The RQLQ(S) is a validated PRO that measures functional impairments due to allergic or non-allergic rhinoconjunctivitis. The assessment consists of 28 questions related to nose symptoms, eye symptoms, non-eye/nose symptoms, sleep problems, practical problems, activity limitations, and emotional function. Each item is scored from 0 (no impairment) to 6 (severely impaired). An overall score is calculated from the mean of the 28 item responses. Domain scores are the mean of the item scores within that domain. |
| Patient Satisfaction Questionnaire | Through 12 months post treatment | Percent of participants indicating satisfaction with the procedure outcome. The satisfaction questionnaire consists of 3 questions that the participant answers at each follow-up visit. The questions indicate whether the participant is satisfied with the procedure outcome, whether the participant would undergo the procedure again for similar results, and whether the participant would recommend the procedure to family or friends with a similar condition. For each item the participant indicates agreement/disagreement with each statement. |
| Serious Device- and/or Procedure-related Adverse Events | Through 12 months post procedure | The number of participants with one or more serious adverse events that are possibly, probably, or definitely related to the ClariFix device and/or procedure. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ClariFix Cryotherapy of the nasal passages with the ClariFix device.
ClariFix cryotherapy: Bilateral freeze ablation of nasal tissue using the ClariFix device. | 68 |
| Sham Sham cryotherapy of the nasal passages with the ClariFix device
Sham ClariFix cryotherapy: Bilateral sham ablation procedure using the ClariFix device. | 65 |
| Total | 133 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Missed follow up | 1 | 1 |
| Overall Study | Procedure Canceled | 1 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | ClariFix | Sham | Total |
|---|---|---|---|
| Age, Continuous | 52.3 years STANDARD_DEVIATION 15.8 | 58.3 years STANDARD_DEVIATION 16.4 | 55.2 years STANDARD_DEVIATION 16.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 5 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) White | 61 Participants | 57 Participants | 118 Participants |
| Region of Enrollment United States | 68 participants | 65 participants | 133 participants |
| Sex: Female, Male Female | 45 Participants | 32 Participants | 77 Participants |
| Sex: Female, Male Male | 23 Participants | 33 Participants | 56 Participants |
| Type of rhinitis (nonallergic rhinitis) | 39 Participants | 37 Participants | 76 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 33 / 68 | 4 / 65 |
| other Total, other adverse events | 33 / 68 | 4 / 65 |
| serious Total, serious adverse events | 1 / 68 | 1 / 65 |
Outcome results
Primary
rTNSS Responder Rate
Responders are defined as participants with a 30% or greater reduction in reflective Total Nasal Symptom Score (rTNSS) relative to baseline. The active treatment will be compared with the sham treatment. The reflective Total Nasal Symptom Score (rTNSS) is a validated PRO consisting of 4 nasal symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing that are assessed over the previous 2-week period. Each symptom is rated on a scale of 0 (no symptoms) to 3 (severe symptoms) and the scores are summed to provide a total rTNSS with a possible range of 0 to 12.
Time frame: 90-days post treatment
Population: 1active ClariFix arm participant returned for the follow up visit, but did not complete the rTNSS
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ClariFix | rTNSS Responder Rate | 47 Participants |
| Sham | rTNSS Responder Rate | 23 Participants |
Secondary
Change in Total RQLQ(S)
Mean change from baseline in the Standardized Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ(S)) score. The RQLQ(S) is a validated PRO that measures functional impairments due to allergic or non-allergic rhinoconjunctivitis. The assessment consists of 28 questions related to nose symptoms, eye symptoms, non-eye/nose symptoms, sleep problems, practical problems, activity limitations, and emotional function. Each item is scored from 0 (no impairment) to 6 (severely impaired). An overall score is calculated from the mean of the 28 item responses. Domain scores are the mean of the item scores within that domain.
Time frame: Through 12 months post treatment
Secondary
Patient Satisfaction Questionnaire
Percent of participants indicating satisfaction with the procedure outcome. The satisfaction questionnaire consists of 3 questions that the participant answers at each follow-up visit. The questions indicate whether the participant is satisfied with the procedure outcome, whether the participant would undergo the procedure again for similar results, and whether the participant would recommend the procedure to family or friends with a similar condition. For each item the participant indicates agreement/disagreement with each statement.
Time frame: Through 12 months post treatment
Secondary
rTNSS Responder Rate
Mean change from baseline in the rTNSS. The reflective Total Nasal Symptom Score (rTNSS) is a validated PRO consisting of 4 nasal symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing that are assessed over the previous 2-week period. Each symptom is rated on a scale of 0 (no symptoms) to 3 (severe symptoms) and the scores are summed to provide a total rTNSS with a possible range of 0 to 12.
Time frame: Through 12 months post treatment
Secondary
Serious Device- and/or Procedure-related Adverse Events
The number of participants with one or more serious adverse events that are possibly, probably, or definitely related to the ClariFix device and/or procedure.
Time frame: Through 12 months post procedure