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Feasibility of treatment at multiple sites with the ClariFix cryoablation device for treatment of chronic rhinitis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Treatment | Experimental | Cryotherapy of the posterior nasal nerve using the ClariFix device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ClariFix | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Study duration (90-days) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Day of treatment during procedure and for up to 1 hour post procedure |
| Change From Baseline in the Reflective Total Nasal Symptom Score (rTNSS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Yen, MD | Specialty Physician Associates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Francisco Otolaryngology Medical Group | San Francisco | California | 94108 | United States | ||
| Bethlehem ENT |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 30 Days |
| |||||||||||||
| 90 Days (Primary Endpoint) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | 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. | All enrolled participants | Posted | Count of Participants | Participants | Study duration (90-days) |
|
|
Adverse events were collected through the study duration of 90 day after the ClariFix procedure.
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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 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pr. 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 | Yes | No | No | Study Protocol | Oct 30, 2018 | Jun 30, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 11, 2019 | Jun 30, 2020 | SAP_001.pdf |
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Prospective, non-randomized, feasibility study of multi-treatment locations
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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. |
| 30 and 90 days after treatment |
| 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. | 30 and 90 days after treatment |
| Bethlehem |
| Pennsylvania |
| 18017 |
| United States |
| Tracy Byerly, MD | Fredericksburg | Texas | 78624 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| 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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| Number with allergic rhinitis | Count of Participants | Participants |
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| Number with nonallergic rhinitis | Count of Participants | Participants |
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| Participants |
|
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| 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). | All enrolled participants | Posted | Mean | Standard Deviation | score on a scale | Day of treatment during procedure and for up to 1 hour post procedure |
|
|
|
| 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. | All enrolled participants with the applicable follow-up visit. | Posted | Median | Inter-Quartile Range | score on a scale | 30 and 90 days after treatment |
|
|
|
|
| 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. | All enrolled participants with the applicable follow-up visit. | Posted | Mean | Standard Deviation | score on a scale | 30 and 90 days after treatment |
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|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 22 |
| 30 |
| Postprocedure pain/discomfort | Injury, poisoning and procedural complications | Systematic Assessment |
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| Palate numbness | Injury, poisoning and procedural complications | Systematic Assessment |
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| Nasal discharge | General disorders | Systematic Assessment |
|
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