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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Cryoablation with the ClariFix device |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ClariFix device | Device |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline through 365 days post treatment |
| 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. | Baseline through 365 days post treatment |
| 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. | Baseline through 365 days post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Immediately post treatment |
| Device- and/or Procedure-related Adverse Events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jacob Johnson, MD | San Francisco Otolaryngology Medical Group | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28799727 | Result | Hwang PH, Lin B, Weiss R, Atkins J, Johnson J. Cryosurgical posterior nasal tissue ablation for the treatment of rhinitis. Int Forum Allergy Rhinol. 2017 Oct;7(10):952-956. doi: 10.1002/alr.21991. Epub 2017 Aug 11. |
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27 participants were enrolled and treated with bilateral cryotherapy of the nasal passage (54 treatments).
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | Cryoablation with the ClariFix device |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | Treatment with the ClariFix Device ClariFix Device |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | A total of 27 subjects were enrolled and received bilateral cryosurgery with the ClariFix device (n=54 treatments). | Posted | Number | participants | Baseline through 365 days post treatment |
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1 Year
Adverse events were systematically reported at each follow-up visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | Treatment with the ClariFix Device ClariFix Device | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear blockage | General disorders | Systematic Assessment |
This is a feasibility study based on a small population of participants.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principal Clinical Research & Publications Manager | Stryker ENT | 763-463-1598 | ellen.omalley@stryker.com |
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| ID | Term |
|---|---|
| D012220 | Rhinitis |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
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All adverse events evaluated as possibly, probably, or definitely related to the ClariFix device and/or procedure. |
| Baseline through 90 days post treatment |
| Participants |
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| Age, Continuous | Mean | Full Range | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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. | All participants with follow-up at the indicated visits. | Posted | Mean | Standard Deviation | score on a scale | Baseline through 365 days post treatment |
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| 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. | All treated participants with follow-up at the indicated visits. | Posted | Mean | Standard Deviation | score on a scale | Baseline through 365 days post treatment |
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| 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. | Physician evaluation of ease of use after each ClariFix procedure. | Posted | Count of Units | Procedures | Immediately post treatment | Procedures | Procedures |
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| 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. | All treated participants. | Posted | Count of Participants | Participants | Baseline through 90 days post treatment |
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| 27 |
| 0 |
| 27 |
| 19 |
| 27 |
| Nasal Dryness | General disorders | Systematic Assessment |
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| Epitaxsis | General disorders | Systematic Assessment | Moderate nosebleed |
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| D010038 |
| Otorhinolaryngologic Diseases |
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| 90 Days post treatment |
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| 180 Days post treatment |
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| 365 Days post treatment |
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| 90 Days post treatment |
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| 180 Days post treatment |
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| 365 Days post treatment |
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| Difficult |
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