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A multi-center, prospective, non-randomized, interventional clinical trial to assess the safety and effectiveness of the ClariFix™ device when used to ablate unwanted tissue in the nose of subjects with chronic rhinitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment with the ClariFix Device | Experimental | Bilateral ablation of nasal tissue for treatment of chronic rhinitis |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ClariFix Device | Device | Cryoablation in the nasal passageway using the ClariFix Device |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Symptom Severity | Effectiveness will be assessed by the mean change in nasal symptoms using the 4-symptom rTNSS (reflective Total Nasal Symptom Score). The rTNSS is the sum of 4 individual patient-rated symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, each evaluated using a scale of 0=None, 1=Mild, 2=Moderate, and 3=Severe. The rTNSS has a possible score of 0-12. The reflective scores are based on the participant's evaluation of symptom severity over the preceding 24 hours. A change of 1 or more is considered the minimum clinically important difference. | 90 days post treatment |
| Device- and/or Procedure-related Serious Adverse Events | Safety will be evaluated based on the frequency of device- and/or procedure-related serious adverse events | 90 days post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) | The RQLQ is a validated quality of life questionnaire that evaluates functional problems associated with rhinitis. The questionnaire assess 7 domains: activities, sleep, nose symptoms, eye symptoms, non nose/eye symptoms, practical problems, and emotional function. Each question is scores on a 7-point scale (0=not impaired at all, 6=severely impaired). A domain and total scores are based on the mean of all answered items in that domain resulting in domain or total scores ranging from 0 to 6. An average change on 0.5 or more is considered a minimal clinically important difference. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Symptom Severity | Median change in nasal symptoms using the 4-symptom rTNSS (reflective Total Nasal Symptom Score). The rTNSS is the sum of 4 individual patient-rated symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, each evaluated using a scale of 0=None, 1=Mild, 2=Moderate, and 3=Severe. The rTNSS has a possible score of 0-12. The reflective scores are based on the participant's evaluation of symptom severity over the preceding 24 hours. A change of 1 point or more is considered the minimum clinically important difference. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| California Sleep Institute | East Palo Alto | California | 94303 | United States | ||
| Sacramento Ear, Nose, and Throat |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31566744 | Result | Chang MT, Song S, Hwang PH. Cryosurgical ablation for treatment of rhinitis: A prospective multicenter study. Laryngoscope. 2020 Aug;130(8):1877-1884. doi: 10.1002/lary.28301. Epub 2019 Sep 30. | |
| 33616224 | Result | Ow RA, O'Malley EM, Han JK, Lam KK, Yen DM. Cryosurgical Ablation for Treatment of Rhinitis: Two-Year Results of a Prospective Multicenter Study. Laryngoscope. 2021 Sep;131(9):1952-1957. doi: 10.1002/lary.29453. Epub 2021 Feb 22. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment With the ClariFix Device | Bilateral ablation of nasal tissue for treatment of chronic rhinitis ClariFix Device: Cryoablation in the nasal passageway using the ClariFix Device |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Initial Study Protocol (12-month FU) |
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| Long-term Extension (15-24 Month FU) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment With the ClariFix Device | Bilateral ablation of nasal tissue for treatment of chronic rhinitis ClariFix Device: Cryoablation in the nasal passageway using the 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, Continuous | Mean |
| 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 | Change From Baseline in Symptom Severity | Effectiveness will be assessed by the mean change in nasal symptoms using the 4-symptom rTNSS (reflective Total Nasal Symptom Score). The rTNSS is the sum of 4 individual patient-rated symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, each evaluated using a scale of 0=None, 1=Mild, 2=Moderate, and 3=Severe. The rTNSS has a possible score of 0-12. The reflective scores are based on the participant's evaluation of symptom severity over the preceding 24 hours. A change of 1 or more is considered the minimum clinically important difference. | All treated participants with 90-day follow-up. | Posted | Mean | Standard Deviation | score on a scale | 90 days post treatment |
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All adverse events from procedure through 9 months post treatment.
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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 | Treatment With the ClariFix Device | Bilateral ablation of nasal tissue for treatment of chronic rhinitis ClariFix Device: Cryoablation in the nasal passageway using the ClariFix Device |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Foot infection | Infections and infestations | Systematic Assessment | HIV-positive patient developed an infection after stepping on a piece of glass at 23 days post treatment. Not related to the study device or procedure. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principal Clinical Research & Publications Manager | Stryker ENT | 763-463-1598 | ellen.omalley@stryker.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 4, 2018 | Oct 15, 2019 | Prot_SAP_000.pdf |
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| 90 days post treatment |
| 1, 3, 6, 9, 12, 15, 18, 21, and 24 months post procedure |
| Sacramento |
| California |
| 95661 |
| United States |
| San Francisco Otolaryngology Medical Group | San Francisco | California | 94108 | United States |
| Ear, Nose, and Throat Associates of South Florida | Boca Raton | Florida | 33487 | United States |
| Bethlehem Ear, Nose, and Throat | Bethlehem | Pennsylvania | 18017 | United States |
| EVMS Otolaryngology | Norfolk | Virginia | 23507 | United States |
| Death |
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| 21-month Follow-up | 6 participants missed the 21-month visit. |
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| 24-month Follow-up |
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| COMPLETED |
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| NOT COMPLETED |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Rhinitis subtype | Count of Participants | Participants |
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| Baseline rTNSS | The reflective Total Nasal Symptom Score (rTNSS) is a validated patient-reported outcome (PRO) used to describe symptoms of rhinitis. The assessment consists of 4 nasal symptom domains (runny nose [rhinorrhea], itchy nose, sneezing, and stuffiness [nasal congestion]). Each item is rated from 0 (absent) to 3 (severe). The 4 domains are added together to provide an overall score ranging from 0 to 12. | Mean | Standard Deviation | units on a scale |
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| Primary | Device- and/or Procedure-related Serious Adverse Events | Safety will be evaluated based on the frequency of device- and/or procedure-related serious adverse events | All treated participants. | Posted | Number | events | 90 days post treatment |
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| Secondary | Change From Baseline in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) | The RQLQ is a validated quality of life questionnaire that evaluates functional problems associated with rhinitis. The questionnaire assess 7 domains: activities, sleep, nose symptoms, eye symptoms, non nose/eye symptoms, practical problems, and emotional function. Each question is scores on a 7-point scale (0=not impaired at all, 6=severely impaired). A domain and total scores are based on the mean of all answered items in that domain resulting in domain or total scores ranging from 0 to 6. An average change on 0.5 or more is considered a minimal clinically important difference. | All treated participants with 90-day follow-up. | Posted | Mean | Standard Deviation | score on a scale | 90 days post treatment |
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| Other Pre-specified | Change From Baseline in Symptom Severity | Median change in nasal symptoms using the 4-symptom rTNSS (reflective Total Nasal Symptom Score). The rTNSS is the sum of 4 individual patient-rated symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, each evaluated using a scale of 0=None, 1=Mild, 2=Moderate, and 3=Severe. The rTNSS has a possible score of 0-12. The reflective scores are based on the participant's evaluation of symptom severity over the preceding 24 hours. A change of 1 point or more is considered the minimum clinically important difference. | All participants with rTNSS scores. | Posted | Median | Inter-Quartile Range | score on a scale | 1, 3, 6, 9, 12, 15, 18, 21, and 24 months post procedure |
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| 4 |
| 100 |
| 9 |
| 100 |
| 0 |
| 100 |
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| Colectomy | Gastrointestinal disorders | Systematic Assessment | Patient with history of colon cancer had a partial colectomy at 250 days post treatment. Not related to the study device or procedure. |
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| Sacroiliac joint dysfunction | Musculoskeletal and connective tissue disorders | Systematic Assessment | Patient underwent surgeries to treat pre-existing bilateral sacroiliac joint dysfunction at 64 and 113 days post treatment. Not related to the study device or procedure. |
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| Retained pledget/epistaxis | Surgical and medical procedures | Systematic Assessment | A retained pledget was removed from the patient's nose 19 days post treatment and resulted in profuse epistaxis. The event was related to the study procedure. |
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| Myocardial infarction | Cardiac disorders | Systematic Assessment | Myocardial infarction with stent placement at 359 days post procedure. Not related to study device or procedure. |
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| Carotid stenosis | Vascular disorders | Systematic Assessment | Carotid stenosis treated with surgery at 711 days post procedure. Not related to the study device or procedure. |
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| Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment | Participants with various cancers (breast, gastric, liver, and brain) died during the study. None of the deaths were related to the study device or procedure. |
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| Sinus bradycardia | Cardiac disorders | Systematic Assessment | Participant underwent pacemaker placement at 592 days post procedure. Not related to the study device or procedure. |
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| Nasal obstruction | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Participant underwent surgical procedures for nasal obstruction at 519 and 682 days post procedure. Not related to the study device or procedure. |
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| 6-month |
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| 9-month |
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| 12-month |
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| 15-month |
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| 18-month |
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| 21-month |
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