A Study of RhinAer ARC Stylus for Treating Chronic Rhinitis (RELIEF)

Not Applicable

Active, not recruiting

• Conditions: Chronic Rhinitis
• Interventions: Device: RhinAer ARC Stylus

• Registration Number: NCT04614324
• Lead Sponsor: Aerin Medical

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.

Study Timeline

• Study Start: 2020-10-05
• Study First Submitted: 2020-10-27
• Study First Submitted QC: 2020-11-02
• Study First Posted: 2020-11-04
• Primary Completion: 2021-06-30
• Results First Submitted: 2023-11-30
• Results First Submitted QC: 2024-07-26
• Results First Posted: 2024-08-21
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-05-06
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 129

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RhinAer ARC Stylus Treatment	RhinAer ARC Stylus	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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).
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
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 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.

Trial Locations

Locations (15)

Arizona Desert ENT Specialists; 🇺🇸 Goodyear, Arizona, United States

Sacramento ENT; 🇺🇸 Roseville, California, United States

ENT Associates of South Florida; 🇺🇸 Boca Raton, Florida, United States

Chicago Nasal and Sinus Center; 🇺🇸 Chicago, Illinois, United States

ENT and Allergy Associates of Florida; 🇺🇸 Port Saint Lucie, Florida, United States

Baton Rouge General / Sinus and Nasal Specialists of Louisiana; 🇺🇸 Baton Rouge, Louisiana, United States

HNO-ZENTRUM am Kudamm; 🇩🇪 Berlin, Germany

ENT and Allergy Associates of Texas; 🇺🇸 McKinney, Texas, United States

Fort Worth ENT; 🇺🇸 Fort Worth, Texas, United States

Universitatsklinikum Carl Gustav Carus Dresden; 🇩🇪 Dresden, Germany

Facharzt für Hals- Nasen- und Ohrenkrankheiten Allergologie Plastische Operationen; 🇩🇪 Göttingen, Germany

University of California, San Francisco; 🇺🇸 San Francisco, California, United States

Florida ENT and Allergy; 🇺🇸 Tampa, Florida, United States

Advanced ENT and Allergy; 🇺🇸 Louisville, Kentucky, United States

Piedmont ENT Associates; 🇺🇸 Winston-Salem, North Carolina, United States