An interventional study of RhinAer ARC Stylus in Chronic Rhinitis, sponsored by Aerin Medical. Completed at 15 sites in 2 countries. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by Aerin Medical · Not applicable, Interventional, and Treatment
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.
246 studies on the registry are indexed under Rhinitis; 22 are open to participants now.
This study's enrollment of 129 is above the median of 80 across 187 interventional studies indexed under Rhinitis.
Browse Rhinitis studies →Aerin Medical is the lead sponsor of 15 studies on the registry; 1 is open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 7 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: RhinAer ARC Stylus
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).
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
Time frame: Baseline and 3 months post study procedure
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
Time frame: 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: * 0 = not troubled * 1 = hardly troubled at all * 2 = somewhat troubled * 3 = moderately troubled * 4 = quite a bit troubled * 5 = very troubled * 6 = extremely troubled. 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).
Time frame: 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: * 0 = not troubled * 1 = hardly troubled at all * 2 = somewhat troubled * 3 = moderately troubled * 4 = quite a bit troubled * 5 = very troubled * 6 = extremely troubled. The total or overall MiniRQLQ score is the mean of the 14 responses range (0-6).
Time frame: 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
Time frame: 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: * 0 = absent symptoms (no sign/symptom is evident) * 1 = mild symptoms (sign/symptom present, but minimal awareness; easily tolerated) * 2 = moderate symptoms (definite awareness of sign/symptom that is bothersome but tolerable) * 3 = severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping). 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.
Time frame: 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: * 0 = absent symptoms (no sign/symptom is evident) * 1 = mild symptoms (sign/symptom present, but minimal awareness; easily tolerated) * 2 = moderate symptoms (definite awareness of sign/symptom that is bothersome but tolerable) * 3 = severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping). 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.
Time frame: 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: * 0 = absent symptoms (no sign/symptom is evident) * 1 = mild symptoms (sign/symptom present, but minimal awareness; easily tolerated) * 2 = moderate symptoms (definite awareness of sign/symptom that is bothersome but tolerable) * 3 = severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping). 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.
Time frame: 6 Months
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.
| Milestone | Treatment Arm |
|---|---|
| Started | 129 |
| 3month | 128 |
| 6 month | 123 |
| Completed | 0 |
| Not completed | 129 |
| Withdrew: Lost to follow-up | 3 |
| Withdrew: Physician decision | 1 |
| Withdrew: Withdrawal by subject | 2 |
| Withdrew: Remaining in follow up | 123 |
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
| Change in rTNSS score from baseline | Treatment Arm |
|---|---|
| Mean Change of the Reflective Total Nasal Symptoms Score (rTNSS) | -4.2 (-4.6 to -3.7) |
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
| percentage of participants | RhinAer ARC Stylus Treatment |
|---|---|
| Participant Responder Percentage | 76.2 (68.1 to 82.8) |
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: * 0 = not troubled * 1 = hardly troubled at all * 2 = somewhat troubled * 3 = moderately troubled * 4 = quite a bit troubled * 5 = very troubled * 6 = extremely troubled. 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).
| score on a scale | Treatment Arm |
|---|---|
| 3 Month - Mean Change in Mini Rhinoconjuctivitis Quality of Life Questionnaire (Mini RQLQ) | -1.8 (-1.8 to -1.4) |
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: * 0 = not troubled * 1 = hardly troubled at all * 2 = somewhat troubled * 3 = moderately troubled * 4 = quite a bit troubled * 5 = very troubled * 6 = extremely troubled. The total or overall MiniRQLQ score is the mean of the 14 responses range (0-6).
| score on a scale | Treatment Arm |
|---|---|
| 6 Months - Mean Change in Mini Rhinoconjuctivitis Quality of Life Questionnaire (Mini RQLQ) | 1.17 ± 1.0 |
Evaluate profile by characterizing the type and frequency of adverse events reported at or following the study procedure an throughout the follow up period
| Participants | Treatment Arm |
|---|---|
| Number of Participants With Device Related Adverse Events | 0 |
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: * 0 = absent symptoms (no sign/symptom is evident) * 1 = mild symptoms (sign/symptom present, but minimal awareness; easily tolerated) * 2 = moderate symptoms (definite awareness of sign/symptom that is bothersome but tolerable) * 3 = severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping). 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.
| score on a scale | Treatment Arm |
|---|---|
| rTNSS Scores at 3 Months | 3.56 ± 2.28 |
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: * 0 = absent symptoms (no sign/symptom is evident) * 1 = mild symptoms (sign/symptom present, but minimal awareness; easily tolerated) * 2 = moderate symptoms (definite awareness of sign/symptom that is bothersome but tolerable) * 3 = severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping). 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.
| score on a scale | Treatment Arm |
|---|---|
| rTNSS Score at 6 Months | 2.85 ± 2.24 |
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: * 0 = absent symptoms (no sign/symptom is evident) * 1 = mild symptoms (sign/symptom present, but minimal awareness; easily tolerated) * 2 = moderate symptoms (definite awareness of sign/symptom that is bothersome but tolerable) * 3 = severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping). 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.
| score on a scale | Treatment Arm |
|---|---|
| rTNSS Change From Baseline at 6 Months Post Procedure | -4.90 ± 2.92 |
Collected over 3 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment Arm | 0/129 (0%) | 0/129 (0%) | 0/129 (0%) |
| Age, Categorical(Participants) | Treatment Arm |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 105 |
| >=65 years | 24 |
| Sex: Female, Male(Participants) | Treatment Arm |
|---|---|
| Female | 69 |
| Male | 60 |
| Ethnicity (NIH/OMB)(Participants) | Treatment Arm |
|---|---|
| Hispanic or Latino | 6 |
| Not Hispanic or Latino | 123 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Treatment Arm |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 4 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 5 |
| White | 117 |
| More than one race | 0 |
| Unknown or Not Reported | 3 |
| Body Mass Index(Participants) | Treatment Arm |
|---|---|
| Underweight (<18.5) kg/m^2 | 4 |
| Normal (18.5-<25) kg/m^2 | 47 |
| Overweight (25-<30) kg/m^2 | 46 |
| Obese (30 & greater) kg/m^2 | 32 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — No data collected will be shared with other researchers participating in the study
Ran from Oct 2020 to primary completion in Jun 2021, 8 months.
Results were first posted in Aug 2024, 3 years 1 month after primary completion.
Of 22 industry-sponsored interventional studies with no phase under Rhinitis, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 18. This study's 8 months is close to that.
Counting every sponsor, half of 38 studies reached it within 11 months; a quarter within 5 and three quarters within 25.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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