An interventional study of ClariFix cryotherapy and Sham ClariFix cryotherapy in Chronic Rhinitis, sponsored by Stryker Instruments. Completed at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2025-03-26.
Sponsored by Stryker Instruments · Not applicable, Interventional, and Treatment
A randomized, sham-controlled, single-blind study of cryotherapy as a treatment for chronic rhinitis.
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.
1,105 studies on the registry are indexed under Rhinitis; 65 are open to participants now.
This study's enrollment of 133 is above the median of 89 across 906 interventional studies indexed under Rhinitis.
Browse Rhinitis studies →Stryker Instruments is the lead sponsor of 6 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Cryotherapy of the nasal passages with the ClariFix device.
Device: ClariFix cryotherapy
Sham cryotherapy of the nasal passages with the ClariFix device
Device: Sham ClariFix cryotherapy
Bilateral freeze ablation of nasal tissue using the ClariFix device.
Bilateral sham ablation procedure using the ClariFix device.
Also known as: Sham
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
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
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
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
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
| Milestone | ClariFix | Sham |
|---|---|---|
| Started | 68 | 65 |
| Completed | 65 | 63 |
| Not completed | 3 | 2 |
| Withdrew: Procedure canceled | 1 | 1 |
| Withdrew: Missed follow up | 1 | 1 |
| Withdrew: Withdrawal by subject | 1 | 0 |
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.
| Participants | ClariFix | Sham |
|---|---|---|
| rTNSS Responder Rate | 47 | 23 |
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
Collected over Screening through 90 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ClariFix | 33/68 (48.5%) | 1/68 (1.5%) | 33/68 (48.5%) |
| Sham | 4/65 (6.2%) | 1/65 (1.5%) | 4/65 (6.2%) |
| Event | ClariFix | Sham |
|---|---|---|
| HemoptysisRespiratory, thoracic and mediastinal disorders | 0/68 | 1/65 |
| Panic AttackPsychiatric disorders | 1/68 | 0/65 |
| Event | ClariFix | Sham |
|---|---|---|
| Pain/discomfort at treatment siteSurgical and medical procedures | 25/68 | 1/65 |
| OtherGeneral disorders | 8/68 | 3/65 |
| Age, Continuous(years) | ClariFix | Sham | Total |
|---|---|---|---|
| Median | 52.3 ± 15.8 | 58.3 ± 16.4 | 55.2 ± 16.3 |
| Sex: Female, Male(Participants) | ClariFix | Sham | Total |
|---|---|---|---|
| Female | 45 | 32 | 77 |
| Male | 23 | 33 | 56 |
| Race (NIH/OMB)(Participants) | ClariFix | Sham | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 2 | 2 | 4 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 3 | 5 | 8 |
| White | 61 | 57 | 118 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 1 | 2 |
| Region of Enrollment(participants) | ClariFix | Sham | Total |
|---|---|---|---|
| United States | 68 | 65 | 133 |
| Type of rhinitis (nonallergic rhinitis)(Participants) | ClariFix | Sham | Total |
|---|---|---|---|
| Count of participants | 39 | 37 | 76 |
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