Chronic Rhinitis
Conditions
Brief summary
Post-market study to continue to evaluate the effectiveness of the RhinAer ARC Stylus for chronic rhinitis.
Detailed description
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.
Interventions
DEVICERhinAer 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).
Sponsors
Aerin Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Active treatment for all subject enrolling prospectively
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
1. Age 18 to 85 years (inclusively). 2. Willing and able to provide informed consent. 3. Willing and able to comply with the subject-specific requirements outlined in the Study Protocol. 4. Seeking treatment for chronic rhinitis symptoms of at least 6 months duration and willing to undergo an office-based procedure. 5. Moderate to severe symptoms of rhinorrhea (rTNSS rating of 2 or 3 for rhinorrhea). 6. Mild to severe symptoms of nasal congestion (rTNSS rating of 1, 2 or 3 for congestion). 7. rTNSS ≥ 6.
Exclusion criteria
1. Anatomic obstructions that in the investigator's opinion limit access to the posterior nasal passage. 2. Altered anatomy of the posterior nose as a result of prior sinus or nasal surgery or injury. 3. Active nasal or sinus infection. 4. History of significant dry eye. 5. History of any of the following: chronic epistaxis, documented episodes of significant nose bleeds in the past 3 months, rhinitis medicamentosa, head or neck irradiation. 6. Have rhinitis symptoms only on a seasonal basis due to allergies. 7. Known or suspected allergies or contraindications to the anesthetic agents and/or antibiotic medications to be used during the study procedure session. 8. Known or suspected to be pregnant or is lactating. 9. Participating in another clinical research study. 10. Has any condition that predisposes to excessive bleeding. 11. Is taking anticoagulants (eg, warfarin, Plavix) or 325 mg aspirin that cannot be discontinued before the procedure. 12. Has previous procedure or surgery for chronic rhinitis. 13. Other medical conditions which in the opinion of the investigator would predispose the subject to poor wound healing, increased surgical risk, or poor compliance with the requirements of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change of the Reflective Total Nasal Symptoms Score (rTNSS) | Baseline and 3 months post study procedure | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participant Responder Percentage | Baseline and 3 months post study procedure | 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 |
| 3 Month - Mean Change in Mini Rhinoconjuctivitis Quality of Life Questionnaire (Mini RQLQ) | Baseline and 3 months post study procedure | 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). |
| 6 Months - Mean Change in Mini Rhinoconjuctivitis Quality of Life Questionnaire (Mini RQLQ) | 6 Months | 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). |
| Number of Participants With Device Related Adverse Events | Baseline and 3 months post study procedure | Evaluate profile by characterizing the type and frequency of adverse events reported at or following the study procedure an throughout the follow up period |
| rTNSS Scores at 3 Months | 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. |
| rTNSS Score at 6 Months | 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. |
| rTNSS Change From Baseline at 6 Months Post Procedure | 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. |
Countries
Germany, United States
Participant flow
Recruitment details
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.
Pre-assignment details
There was no wash out or run in for this study
Participants by arm
| Arm | Count |
|---|---|
| Treatment Arm Open Label, Single Arm Study - All subjects meeting eligibility requirements receive the Rhinaer Procedure | 129 |
| Total | 129 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Remaining in Follow up | 123 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Treatment Arm |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 24 Participants |
| Age, Categorical Between 18 and 65 years | 105 Participants |
| Body Mass Index Normal (18.5-<25) kg/m^2 | 47 Participants |
| Body Mass Index Obese (30 & greater) kg/m^2 | 32 Participants |
| Body Mass Index Overweight (25-<30) kg/m^2 | 46 Participants |
| Body Mass Index Underweight (<18.5) kg/m^2 | 4 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 123 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 117 Participants |
| Sex: Female, Male Female | 69 Participants |
| Sex: Female, Male Male | 60 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 129 |
| other Total, other adverse events | 0 / 129 |
| serious Total, serious adverse events | 0 / 129 |
Outcome results
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
Time frame: Baseline and 3 months post study procedure
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Treatment Arm | Mean Change of the Reflective Total Nasal Symptoms Score (rTNSS) | -4.2 Change in rTNSS score from baseline |
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: * 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
Population: 127 subjects with MiniRQLQ scores at baseline and 3 months post treatment
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Treatment Arm | 3 Month - Mean Change in Mini Rhinoconjuctivitis Quality of Life Questionnaire (Mini RQLQ) | -1.8 score on a scale |
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: * 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
Population: Enrolled Subjects continuing at 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Arm | 6 Months - Mean Change in Mini Rhinoconjuctivitis Quality of Life Questionnaire (Mini RQLQ) | 1.17 score on a scale | Standard Deviation 1 |
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
Time frame: Baseline and 3 months post study procedure
Population: \# of subjects experienced Device Related Adverse Event at 3months post treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment Arm | Number of Participants With Device Related Adverse Events | 0 Participants |
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
Time frame: Baseline and 3 months post study procedure
Population: patients with an rTNSS at baseline and 3 months post procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment Arm | Participant Responder Percentage | 76.2 percentage of participants |
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: * 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
Population: Subject continued on through 6 months. (3 lost to follow-up, 2 withdrew-consent, 1 withdrew by physician )
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Arm | rTNSS Change From Baseline at 6 Months Post Procedure | -4.90 score on a scale | Standard Deviation 2.92 |
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: * 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
Population: subjects treated and continuing on to 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Arm | rTNSS Score at 6 Months | 2.85 score on a scale | Standard Deviation 2.24 |
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: * 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
Population: Enrolled Subjects
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Arm | rTNSS Scores at 3 Months | 3.56 score on a scale | Standard Deviation 2.28 |