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Post-market study to continue to evaluate the effectiveness of the RhinAer ARC Stylus for chronic rhinitis.
Prospective, Open Label, Multicenter Study of the Aerin Medical RhinAer® ARC Stylus for Chronic Rhinitis to continue to evaluate the effectiveness of the RhinAer® ARC Stylus for treating the posterior nasal nerve area to improve symptoms in adults diagnosed with chronic rhinitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RhinAer ARC Stylus Treatment | Experimental | The RhinAer procedure will be performed in the study clinic using the RhinAer Stylus and Aerin Console. The RhinAer Stylus is a disposable handheld device capable of delivering bipolar radiofrequency energy to tissue when connected to the Aerin Console radiofrequency generating device. Participants will have both nostrils treated in the portion of the nasal cavity mucosa overlying the region of the posterior nasal nerve. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RhinAer ARC Stylus | Device | The RhinAer procedure incorporates use of the RhinAer Stylus (Model FG815), which is a cleared (FDA - K192471) disposable handheld device capable of delivering bipolar radiofrequency energy to tissue. RhinAer has CE Marking in EU. The Aerin Console (Model FG226) RF generator with temperature control capable of delivering very low doses of energy was cleared for use in the US (FDA - K162810) and has CE Marking in the EU (CE639608). |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change of the Reflective Total Nasal Symptoms Score (rTNSS) | The rTNSS (Total Nasal Symptom Score) is a brief questionnaire developed to assess the severity of symptoms in individuals with rhinitis, particularly allergic rhinitis The questionnaire consists of questions that evaluate the following 4 symptoms of Nasal Congestion, Runny Nose, Nasal Itching and Sneezing. Each symptom is rated on a 4-point scale from "0" (no symptoms), "1" (mild symptoms), "2" (moderate symptoms" and "3" (severe symptoms). The total score is calculated by summing up the individual scores for each symptom. The total score is the sum of the 4 nasal symptoms. A low score indicates lower symptoms, a higher score indicates more symptoms. Range of score is 0-12 This questionnaire was provided to subjects at baseline and again at 3 months post procedure. This outcome measure shows the difference in overall scores. The average change in the score between baseline and 3M | Baseline and 3 months post study procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Participant Responder Percentage | The rTNSS (Total Nasal Symptom Score) is a brief questionnaire developed to assess the severity of symptoms in individuals with rhinitis, particularly allergic rhinitis The questionnaire consists of questions that evaluate the following symptoms of Nasal Congestion, Runny Nose, Nasal Itching and Sneezing. Each symptom is rated on a 4-point scale from "0" (no symptoms) to "3" (severe symptoms). The total score is calculated by summing up the individual scores for each symptom. The total score is the sum of the 4 nasal symptoms. A low score indicates lower symptoms, a higher score indicates more symptoms. This questionnaire was provided to subjects at baseline and again at 3 months post procedure. This outcome measure shows the percentage of participants who responded to the procedure with improved rTNSS score |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Desert ENT Specialists | Goodyear | Arizona | 85395 | United States | ||
| Sacramento ENT |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37916848 | Result | Lee JT, Abbas GM, Charous DD, Cuevas M, Goktas O, Loftus PA, Nachlas NE, Toskala EM, Watkins JP, Brehmer D. Two-Year Outcomes After Radiofrequency Neurolysis of Posterior Nasal Nerve in Chronic Rhinitis. Laryngoscope. 2024 May;134(5):2077-2084. doi: 10.1002/lary.31120. Epub 2023 Nov 2. | |
| 35818709 | Result | Lee JT, Abbas GM, Charous DD, Cuevas PDMM, Goktas PDMO, Loftus PA, Nachlas NE, Toskala EM, Watkins JP, Brehmer PDMD. Clinical and Quality of Life Outcomes Following Temperature-Controlled Radiofrequency Neurolysis of the Posterior Nasal Nerve (RhinAer) for Treatment of Chronic Rhinitis. Am J Rhinol Allergy. 2022 Nov;36(6):747-754. doi: 10.1177/19458924221109987. Epub 2022 Jul 11. |
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No data collected will be shared with other researchers participating in the study
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There was no wash out or run in for this study
Recruitment for this trial occurred between 10/5/2020 and 5/12/21. This prospective single-arm study enrolled patients across 16 centers in the United States (13) and Germany (3). All sites were either medical clinics or academic medical centers.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Arm | Open Label, Single Arm Study - All subjects meeting eligibility requirements receive the Rhinaer Procedure |
| 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 27, 2021 |
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Active treatment for all subject enrolling prospectively
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| Baseline and 3 months post study procedure |
| 3 Month - Mean Change in Mini Rhinoconjuctivitis Quality of Life Questionnaire (Mini RQLQ) | The Rhinoconjuctivitis Quality of Life Questionnaire is validated rhinoconjuctivitis disease-specific instrument. The MiniRQLQ, to be used in this study, was developed and validated for efficiency by reducing the number of questions to 14. The instrument consists of 14 questions across 5 domains (activity limitations (n=3), practical problems (n=2), nose symptoms (n=3), eye symptoms (n=3), and other symptoms (n=3)). Responses are based on a 1-week recall and provided on a 7-point scale:
The total or overall MiniRQLQ score is the mean of the 14 responses (range of 0-6). Developers of the original RQLQ reported MCID for overall miniRQLQ >0.7 with another study indicating 0.42 (95% CI 0.30-0.51). | Baseline and 3 months post study procedure |
| 6 Months - Mean Change in Mini Rhinoconjuctivitis Quality of Life Questionnaire (Mini RQLQ) | The Rhinoconjuctivitis Quality of Life Questionnaire is a well-established, validated, and the most frequently used rhinoconjuctivitis disease-specific instrument. The MiniRQLQ, to be used in this study, was developed and validated to further facilitate ease of use and efficiency by reducing the number of questions to 14. The instrument consists of 14 questions across 5 domains (activity limitations (n=3), practical problems (n=2), nose symptoms (n=3), eye symptoms (n=3), and other symptoms (n=3)). Responses are based on a 1-week recall and provided on a 7-point scale:
The total or overall MiniRQLQ score is the mean of the 14 responses range (0-6). | 6 Months |
| Number of Participants With Device Related Adverse Events | Evaluate profile by characterizing the type and frequency of adverse events reported at or following the study procedure an throughout the follow up period | Baseline and 3 months post study procedure |
| rTNSS Scores at 3 Months | The TNSS is an instrument used to collect patient self-rated severity of nasal symptoms originally comprised of 3 symptoms (nasal obstruction, itching/sneezing and secretion/runny nose) that has been widely adapted to include 4 nasal symptoms: rhinorrhea, nasal congestion, nasal itching, and sneezing. The patient rates 4 nasal symptoms (rhinorrhea, nasal congestion, nasal itching and sneezing) on the following 4-point scale:
The total score is the sum of the 4 nasal symptoms. Range of Scores 0-12 A low score indicates lower symptoms, a higher score indicates more symptoms. | 3 Months |
| rTNSS Score at 6 Months | The TNSS is an instrument used to collect patient self-rated severity of nasal symptoms originally comprised of 3 symptoms (nasal obstruction, itching/sneezing and secretion/runny nose) that has been widely adapted to include 4 nasal symptoms: rhinorrhea, nasal congestion, nasal itching, and sneezing. The patient rates 4 nasal symptoms (rhinorrhea, nasal congestion, nasal itching and sneezing) on the following 4-point scale:
The total score is the sum of the 4 nasal symptoms. Range of Scores 0-12 A low score indicates lower symptoms, a higher score indicates more symptoms. | 6 Months |
| rTNSS Change From Baseline at 6 Months Post Procedure | The TNSS is an instrument used to collect patient self-rated severity of nasal symptoms originally comprised of 3 symptoms (nasal obstruction, itching/sneezing and secretion/runny nose) that has been widely adapted to include 4 nasal symptoms: rhinorrhea, nasal congestion, nasal itching, and sneezing. The patient rates 4 nasal symptoms (rhinorrhea, nasal congestion, nasal itching and sneezing) on the following 4-point scale:
The total score is the sum of the 4 nasal symptoms. Range of Scores 0-12 A low score indicates lower symptoms, a higher score indicates more symptoms. | 6 Months |
| Roseville |
| California |
| 95661 |
| United States |
| University of California, San Francisco | San Francisco | California | 94115 | United States |
| ENT Associates of South Florida | Boca Raton | Florida | 33487 | United States |
| ENT and Allergy Associates of Florida | Port Saint Lucie | Florida | 34952 | United States |
| Florida ENT and Allergy | Tampa | Florida | 33619 | United States |
| Chicago Nasal and Sinus Center | Chicago | Illinois | 60602 | United States |
| Advanced ENT and Allergy | Louisville | Kentucky | 40220 | United States |
| Baton Rouge General / Sinus and Nasal Specialists of Louisiana | Baton Rouge | Louisiana | 70809 | United States |
| Piedmont ENT Associates | Winston-Salem | North Carolina | 27103 | United States |
| Fort Worth ENT | Fort Worth | Texas | 76109 | United States |
| ENT and Allergy Associates of Texas | McKinney | Texas | 75070 | United States |
| HNO-ZENTRUM am Kudamm | Berlin | Germany |
| Universitatsklinikum Carl Gustav Carus Dresden | Dresden | Germany |
| Facharzt für Hals- Nasen- und Ohrenkrankheiten Allergologie Plastische Operationen | Göttingen | Germany |
| 35781952 | Result | Kohlfaerber T, Pieper M, Munter M, Holzhausen C, Ahrens M, Idel C, Bruchhage KL, Leichtle A, Konig P, Huttmann G, Schulz-Hildebrandt H. Dynamic microscopic optical coherence tomography to visualize the morphological and functional micro-anatomy of the airways. Biomed Opt Express. 2022 May 5;13(6):3211-3223. doi: 10.1364/BOE.456104. eCollection 2022 Jun 1. |
| 40760831 | Result | Lee JT, Abbas GM, Charous DD, Cuevas M, Goktas O, Loftus PA, Nachlas NE, Toskala EM, Watkins JP, Brehmer D. Three-Year Outcomes After Temperature-Controlled Radiofrequency Ablation of the Posterior Nasal Nerve for Chronic Rhinitis. Am J Rhinol Allergy. 2025 Nov;39(6):398-409. doi: 10.1177/19458924251360889. Epub 2025 Aug 4. |
| 3Month |
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| 6 Month |
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| COMPLETED | Subjects still in follow up |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Arm | Open Label, Single Arm Study - All subjects meeting eligibility requirements receive the Rhinaer Procedure |
| Units | Counts |
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| 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 | Participants |
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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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| Body Mass Index | BMI stands for Body Mass Index, which is a measure of body fatness based on weight and height. BMI is calculated by dividing weight in kilograms by the square of height in meters | Count of Participants | 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 | Mean Change of the Reflective Total Nasal Symptoms Score (rTNSS) | The rTNSS (Total Nasal Symptom Score) is a brief questionnaire developed to assess the severity of symptoms in individuals with rhinitis, particularly allergic rhinitis The questionnaire consists of questions that evaluate the following 4 symptoms of Nasal Congestion, Runny Nose, Nasal Itching and Sneezing. Each symptom is rated on a 4-point scale from "0" (no symptoms), "1" (mild symptoms), "2" (moderate symptoms" and "3" (severe symptoms). The total score is calculated by summing up the individual scores for each symptom. The total score is the sum of the 4 nasal symptoms. A low score indicates lower symptoms, a higher score indicates more symptoms. Range of score is 0-12 This questionnaire was provided to subjects at baseline and again at 3 months post procedure. This outcome measure shows the difference in overall scores. The average change in the score between baseline and 3M | Posted | Mean | 95% Confidence Interval | Change in rTNSS score from baseline | Baseline and 3 months post study procedure |
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| Secondary | Participant Responder Percentage | The rTNSS (Total Nasal Symptom Score) is a brief questionnaire developed to assess the severity of symptoms in individuals with rhinitis, particularly allergic rhinitis The questionnaire consists of questions that evaluate the following symptoms of Nasal Congestion, Runny Nose, Nasal Itching and Sneezing. Each symptom is rated on a 4-point scale from "0" (no symptoms) to "3" (severe symptoms). The total score is calculated by summing up the individual scores for each symptom. The total score is the sum of the 4 nasal symptoms. A low score indicates lower symptoms, a higher score indicates more symptoms. This questionnaire was provided to subjects at baseline and again at 3 months post procedure. This outcome measure shows the percentage of participants who responded to the procedure with improved rTNSS score | patients with an rTNSS at baseline and 3 months post procedure | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and 3 months post study procedure |
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| Secondary | 3 Month - Mean Change in Mini Rhinoconjuctivitis Quality of Life Questionnaire (Mini RQLQ) | The Rhinoconjuctivitis Quality of Life Questionnaire is validated rhinoconjuctivitis disease-specific instrument. The MiniRQLQ, to be used in this study, was developed and validated for efficiency by reducing the number of questions to 14. The instrument consists of 14 questions across 5 domains (activity limitations (n=3), practical problems (n=2), nose symptoms (n=3), eye symptoms (n=3), and other symptoms (n=3)). Responses are based on a 1-week recall and provided on a 7-point scale:
The total or overall MiniRQLQ score is the mean of the 14 responses (range of 0-6). Developers of the original RQLQ reported MCID for overall miniRQLQ >0.7 with another study indicating 0.42 (95% CI 0.30-0.51). | 127 subjects with MiniRQLQ scores at baseline and 3 months post treatment | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline and 3 months post study procedure |
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| Secondary | 6 Months - Mean Change in Mini Rhinoconjuctivitis Quality of Life Questionnaire (Mini RQLQ) | The Rhinoconjuctivitis Quality of Life Questionnaire is a well-established, validated, and the most frequently used rhinoconjuctivitis disease-specific instrument. The MiniRQLQ, to be used in this study, was developed and validated to further facilitate ease of use and efficiency by reducing the number of questions to 14. The instrument consists of 14 questions across 5 domains (activity limitations (n=3), practical problems (n=2), nose symptoms (n=3), eye symptoms (n=3), and other symptoms (n=3)). Responses are based on a 1-week recall and provided on a 7-point scale:
The total or overall MiniRQLQ score is the mean of the 14 responses range (0-6). | Enrolled Subjects continuing at 6 months | Posted | Mean | Standard Deviation | score on a scale | 6 Months |
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| Secondary | Number of Participants With Device Related Adverse Events | Evaluate profile by characterizing the type and frequency of adverse events reported at or following the study procedure an throughout the follow up period | # of subjects experienced Device Related Adverse Event at 3months post treatment | Posted | Count of Participants | Participants | Baseline and 3 months post study procedure |
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| Secondary | rTNSS Scores at 3 Months | The TNSS is an instrument used to collect patient self-rated severity of nasal symptoms originally comprised of 3 symptoms (nasal obstruction, itching/sneezing and secretion/runny nose) that has been widely adapted to include 4 nasal symptoms: rhinorrhea, nasal congestion, nasal itching, and sneezing. The patient rates 4 nasal symptoms (rhinorrhea, nasal congestion, nasal itching and sneezing) on the following 4-point scale:
The total score is the sum of the 4 nasal symptoms. Range of Scores 0-12 A low score indicates lower symptoms, a higher score indicates more symptoms. | Enrolled Subjects | Posted | Mean | Standard Deviation | score on a scale | 3 Months |
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| Secondary | rTNSS Score at 6 Months | The TNSS is an instrument used to collect patient self-rated severity of nasal symptoms originally comprised of 3 symptoms (nasal obstruction, itching/sneezing and secretion/runny nose) that has been widely adapted to include 4 nasal symptoms: rhinorrhea, nasal congestion, nasal itching, and sneezing. The patient rates 4 nasal symptoms (rhinorrhea, nasal congestion, nasal itching and sneezing) on the following 4-point scale:
The total score is the sum of the 4 nasal symptoms. Range of Scores 0-12 A low score indicates lower symptoms, a higher score indicates more symptoms. | subjects treated and continuing on to 6 months | Posted | Mean | Standard Deviation | score on a scale | 6 Months |
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| Secondary | rTNSS Change From Baseline at 6 Months Post Procedure | The TNSS is an instrument used to collect patient self-rated severity of nasal symptoms originally comprised of 3 symptoms (nasal obstruction, itching/sneezing and secretion/runny nose) that has been widely adapted to include 4 nasal symptoms: rhinorrhea, nasal congestion, nasal itching, and sneezing. The patient rates 4 nasal symptoms (rhinorrhea, nasal congestion, nasal itching and sneezing) on the following 4-point scale:
The total score is the sum of the 4 nasal symptoms. Range of Scores 0-12 A low score indicates lower symptoms, a higher score indicates more symptoms. | Subject continued on through 6 months. (3 lost to follow-up, 2 withdrew-consent, 1 withdrew by physician ) | Posted | Mean | Standard Deviation | score on a scale | 6 Months |
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3 years
The definition for AE and SAE match Clinicaltrials.gov and follow ISO14144. Definitions also include Adverse Device Effect (ADE) ,Serious Adverse Device Effect (SADE), and unanticipated (Serious) Adverse Device Effect (UADE or USADE) based on (21 CFR 812.3)
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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 Arm | Open Label, Single Arm Study - All subjects meeting eligibility requirements receive the Rhinaer Procedure | 0 | 129 | 0 | 129 | 0 | 129 |
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Lack of a control arm and the limited follow-up to date It is possible that placebo effects may have contributed to the overall observed effect.
Medication use was not limited by the protocol Future research is needed to determine cost-benefit analysis.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anais Laborde Sr. Director of Clinical Affairs | Aerin Medical | 650-518-9624 | alaborde@aerinmedical.com |
| Nov 28, 2023 |
| Prot_SAP_000.pdf |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Overweight (25-<30) kg/m^2 |
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| Obese (30 & greater) kg/m^2 |
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