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| Name | Class |
|---|---|
| North American Science Associates Inc. | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ClariFix | Active Comparator | Cryotherapy of the nasal passages with the ClariFix device. |
|
| Sham | Sham Comparator | Sham cryotherapy of the nasal passages with the ClariFix device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ClariFix cryotherapy | Device | Bilateral freeze ablation of nasal tissue using the ClariFix device. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 90-days post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anthony DelSignore, MD | Ichan School of Medicine, Mount Sinai, New York, NY | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ENT Associates of South Florida | Coral Springs | Florida | 33065 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | ClariFix | Cryotherapy of the nasal passages with the ClariFix device. ClariFix cryotherapy: Bilateral freeze ablation of nasal tissue using the ClariFix device. |
| FG001 | Sham | Sham cryotherapy of the nasal passages with the ClariFix device Sham ClariFix cryotherapy: Bilateral sham ablation procedure using the ClariFix device. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | ClariFix | Cryotherapy of the nasal passages with the ClariFix device. ClariFix cryotherapy: Bilateral freeze ablation of nasal tissue using the ClariFix device. |
| BG001 | Sham |
| 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 | Median |
| 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 | 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. | 1active ClariFix arm participant returned for the follow up visit, but did not complete the rTNSS | Posted | Count of Participants | Participants | 90-days post treatment |
|
Screening through 90 days
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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 | ClariFix | Cryotherapy of the nasal passages with the ClariFix device. ClariFix cryotherapy: Bilateral freeze ablation of nasal tissue using the ClariFix device. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Panic Attack | Psychiatric disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain/discomfort at treatment site | Surgical and medical procedures | Systematic Assessment |
Study follow up is ongoing. Only 90 day endpoints are available currently.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robyn Schacherer, Manager Clinical Affairs | Stryker | 763-463-7054 | robyn.schacherer@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 | Aug 20, 2019 | Aug 24, 2021 | Prot_SAP_000.pdf |
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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.
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All participants will be blinded to treatment assignment from procedure through their 90-day visit.
| Sham ClariFix cryotherapy | Device | Bilateral sham ablation procedure using the ClariFix device. |
|
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| 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. | 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. | 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. | Through 12 months post procedure |
| Withdrawal by Subject |
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Sham cryotherapy of the nasal passages with the ClariFix device
Sham ClariFix cryotherapy: Bilateral sham ablation procedure using the ClariFix device.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | 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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| Type of rhinitis (nonallergic rhinitis) | Count of Participants | Participants |
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| OG001 | Sham | Sham cryotherapy of the nasal passages with the ClariFix device Sham ClariFix cryotherapy: Bilateral sham ablation procedure using the ClariFix device. |
|
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| 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. | Not Posted | Dec 2025 | Through 12 months post treatment | 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. | Not Posted | Dec 2025 | Through 12 months post treatment | Participants |
| 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. | Not Posted | Dec 2025 | Through 12 months post treatment | Participants |
| 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. | Not Posted | Dec 2025 | Through 12 months post procedure | Participants |
| 33 |
| 68 |
| 1 |
| 68 |
| 33 |
| 68 |
| EG001 | Sham | Sham cryotherapy of the nasal passages with the ClariFix device Sham ClariFix cryotherapy: Bilateral sham ablation procedure using the ClariFix device. | 4 | 65 | 1 | 65 | 4 | 65 |
| Hemoptysis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Other | General disorders | Systematic Assessment |
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