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| Name | Class |
|---|---|
| American Academy of Otolaryngic Allergy | OTHER |
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The purpose of this study is to assess the effectiveness of radiofrequency ablation (RFA) of the posterior nasal nerve (PNN) in chronic rhinitis (CR) patients by comparing patient reflective total nasal symptom score (rTNSS) and nasal obstruction symptom evaluation (NOSE) , peak nasal inspiratory flow (PNIF) , and levels of Type 2 cytokines pre- and post-procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiofrequency ablation (RFA) | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiofrequency ablation (RFA) | Device | The NEUROMARK device is an in-office, disposable bipolar RFA device with a treatment tip consisting of micro electrodes which delivers RF energy while monitoring appropriate tissue contact to maximize delivery to posterior nasal nerve and its variable branching. After topical anesthesia consisting of oxymetazoline and 1% lido followed by 4% lidocaine, the device will be placed in the posterior inferior turbinate under endoscopic visualization. The device will be activated per manufacturer's instructions |
| Measure | Description | Time Frame |
|---|---|---|
| Nasal Congestion as Assessed by the Peak Nasal Inspiratory Flow (PNIF) | PNIF is used to assess nasal air flow during maximal inspiration, and is reported in liters per minute. | Baseline |
| Nasal Congestion as Assessed by the Peak Nasal Inspiratory Flow (PNIF) | PNIF is used to assess nasal air flow during maximal inspiration, and is reported in liters per minute | 4 weeks post intervention |
| Nasal Congestion as Assessed by the Peak Nasal Inspiratory Flow (PNIF) | PNIF is used to assess nasal air flow during maximal inspiration, and is reported in liters per minute | 12 weeks post intervention |
| Interleukin-10 (IL-10) | cytokine | Baseline |
| Interleukin-22 (IL-22) | cytokine | Baseline |
| Interleukin-10 (IL-10) | cytokine | 12 weeks post intervention |
| Interleukin-22 (IL-22) | cytokine | 12 weeks post intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Nasal Congestion as Assessed by the Reflective Total Nasal Symptom Score (rTNSS) | This is a 4 item questionnaire and each is scored from 0(none) to 3(severe). The sum of the 4 times were added to generate a scale from 0 to 12, a higher number indicating more congestion | Baseline |
| Nasal Congestion as Assessed by the Reflective Total Nasal Symptom Score (rTNSS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Z Allen, MD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Radiofrequency Ablation (RFA) | Radiofrequency ablation (RFA): The NEUROMARK device is an in-office, disposable bipolar RFA device with a treatment tip consisting of micro electrodes which delivers RF energy while monitoring appropriate tissue contact to maximize delivery to posterior nasal nerve and its variable branching. After topical anesthesia consisting of oxymetazoline and 1% lido followed by 4% lidocaine, the device will be placed in the posterior inferior turbinate under endoscopic visualization. The device will be activated per manufacturer's instructions |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 | Jan 19, 2023 |
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This is a 4 item questionnaire and each is scored from 0(none) to 3(severe). The sum of the 4 times were added to generate a scale from 0 to 12, a higher number indicating more congestion |
| 4 weeks post intervention |
| Nasal Congestion as Assessed by the Reflective Total Nasal Symptom Score (rTNSS) | This is a 4 item questionnaire and each is scored from 0(none) to 3(severe). The sum of the 4 times were added to generate a scale from 0 to 12, a higher number indicating more congestion | 12 weeks post intervention |
| Nasal Obstruction as Assessed by the Nasal Obstruction Symptom Evaluation Survey (NOSE) | This is a 5 item self reported questionnaire and each is scored from 0(not a problem) - 4(severe problem). The sum of the 5 items were multiplied by 5, to generate a scale from 0 to 100, a higher score indicated more obstruction. | Baseline |
| Nasal Obstruction as Assessed by the Nasal Obstruction Symptom Evaluation Survey (NOSE) | This is a 5 item self reported questionnaire and each is scored from 0(not a problem) - 4(severe problem). The sum of the 5 items were multiplied by 5, to generate a scale from 0 to 100, a higher score indicated more obstruction. | 4 weeks post intervention |
| Nasal Obstruction as Assessed by the Nasal Obstruction Symptom Evaluation Survey (NOSE) | This is a 5 item self reported questionnaire and each is scored from 0(not a problem) - 4(severe problem). The sum of the 5 items were multiplied by 5, to generate a scale from 0 to 100, a higher score indicated more obstruction. | 12 weeks post intervention |
| Received Intervention |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Radiofrequency Ablation (RFA) | Radiofrequency ablation (RFA): The NEUROMARK device is an in-office, disposable bipolar RFA device with a treatment tip consisting of micro electrodes which delivers RF energy while monitoring appropriate tissue contact to maximize delivery to posterior nasal nerve and its variable branching. After topical anesthesia consisting of oxymetazoline and 1% lido followed by 4% lidocaine, the device will be placed in the posterior inferior turbinate under endoscopic visualization. The device will be activated per manufacturer's instructions |
| 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 | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Nasal Congestion as Assessed by the Peak Nasal Inspiratory Flow (PNIF) | PNIF is used to assess nasal air flow during maximal inspiration, and is reported in liters per minute. | Posted | Median | Inter-Quartile Range | Liters Per Minute | Baseline |
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| Primary | Nasal Congestion as Assessed by the Peak Nasal Inspiratory Flow (PNIF) | PNIF is used to assess nasal air flow during maximal inspiration, and is reported in liters per minute | Data were not collected from 6 participants in the Radiofrequency ablation (RFA) arm. | Posted | Median | Inter-Quartile Range | Liters Per Minute | 4 weeks post intervention |
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| Primary | Nasal Congestion as Assessed by the Peak Nasal Inspiratory Flow (PNIF) | PNIF is used to assess nasal air flow during maximal inspiration, and is reported in liters per minute | Data were not collected from 5 participants in the Radiofrequency ablation (RFA) arm. | Posted | Median | Inter-Quartile Range | Liters Per Minute | 12 weeks post intervention |
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| Primary | Interleukin-10 (IL-10) | cytokine | Posted | Mean | Standard Deviation | picogram per milliliter (pg/mL) | Baseline |
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| Secondary | Nasal Congestion as Assessed by the Reflective Total Nasal Symptom Score (rTNSS) | This is a 4 item questionnaire and each is scored from 0(none) to 3(severe). The sum of the 4 times were added to generate a scale from 0 to 12, a higher number indicating more congestion | Posted | Median | Inter-Quartile Range | score on a scale | Baseline |
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| Secondary | Nasal Congestion as Assessed by the Reflective Total Nasal Symptom Score (rTNSS) | This is a 4 item questionnaire and each is scored from 0(none) to 3(severe). The sum of the 4 times were added to generate a scale from 0 to 12, a higher number indicating more congestion | Data were not collected from 6 participants in the Radiofrequency ablation (RFA) arm. | Posted | Median | Inter-Quartile Range | score on a scale | 4 weeks post intervention |
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| Secondary | Nasal Congestion as Assessed by the Reflective Total Nasal Symptom Score (rTNSS) | This is a 4 item questionnaire and each is scored from 0(none) to 3(severe). The sum of the 4 times were added to generate a scale from 0 to 12, a higher number indicating more congestion | Data were not collected from 5 participants in the Radiofrequency ablation (RFA) arm. | Posted | Median | Inter-Quartile Range | score on a scale | 12 weeks post intervention |
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| Secondary | Nasal Obstruction as Assessed by the Nasal Obstruction Symptom Evaluation Survey (NOSE) | This is a 5 item self reported questionnaire and each is scored from 0(not a problem) - 4(severe problem). The sum of the 5 items were multiplied by 5, to generate a scale from 0 to 100, a higher score indicated more obstruction. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline |
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| Secondary | Nasal Obstruction as Assessed by the Nasal Obstruction Symptom Evaluation Survey (NOSE) | This is a 5 item self reported questionnaire and each is scored from 0(not a problem) - 4(severe problem). The sum of the 5 items were multiplied by 5, to generate a scale from 0 to 100, a higher score indicated more obstruction. | Data were not collected from 6 participants in the Radiofrequency ablation (RFA) arm. | Posted | Median | Inter-Quartile Range | score on a scale | 4 weeks post intervention |
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| Secondary | Nasal Obstruction as Assessed by the Nasal Obstruction Symptom Evaluation Survey (NOSE) | This is a 5 item self reported questionnaire and each is scored from 0(not a problem) - 4(severe problem). The sum of the 5 items were multiplied by 5, to generate a scale from 0 to 100, a higher score indicated more obstruction. | Data were not collected from 5 participants in the Radiofrequency ablation (RFA) arm. | Posted | Median | Inter-Quartile Range | score on a scale | 12 weeks post intervention |
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| Primary | Interleukin-22 (IL-22) | cytokine | Posted | Mean | Standard Deviation | picogram per milliliter (pg/mL) | Baseline |
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| Primary | Interleukin-10 (IL-10) | cytokine | Posted | Mean | Standard Deviation | picogram per milliliter (pg/mL) | 12 weeks post intervention |
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| Primary | Interleukin-22 (IL-22) | cytokine | cytokine | Posted | Mean | Standard Deviation | picogram per milliliter (pg/mL) | 12 weeks post intervention |
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12 weeks
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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 | Radiofrequency Ablation (RFA) | Radiofrequency ablation (RFA): The NEUROMARK device is an in-office, disposable bipolar RFA device with a treatment tip consisting of micro electrodes which delivers RF energy while monitoring appropriate tissue contact to maximize delivery to posterior nasal nerve and its variable branching. After topical anesthesia consisting of oxymetazoline and 1% lido followed by 4% lidocaine, the device will be placed in the posterior inferior turbinate under endoscopic visualization. The device will be activated per manufacturer's instructions | 0 | 17 | 0 | 17 | 3 | 17 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headaches | General disorders | Systematic Assessment |
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| dental infection | Infections and infestations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Z. Allen | The University of Texas Health Science Center at Houston | 713-500-5427 | David.Allen@uth.tmc.edu |
| Feb 14, 2025 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| ID | Term |
|---|---|
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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