A Study of RhinAer ARC Stylus for Treating Chronic Rhinitis (RELIEF) (RELIEF)
A Prospective, Open Label, Multi-Center Study Using the RhinAer Procedure for Treatment of Subjects Suffering With Chronic Rhinitis
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Berlin, Germany
- HNO-ZENTRUM am Kudamm
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Dresden, Germany
- Universitätsklinikum Carl Gustav Carus Dresden
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Göttingen, Germany
- Facharzt für Hals- Nasen- und Ohrenkrankheiten Allergologie Plastische Operationen
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Arizona
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Goodyear, Arizona, United States, 85395
- Arizona Desert ENT Specialists
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California
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Roseville, California, United States, 95661
- Sacramento ENT
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San Francisco, California, United States, 94115
- University of California, San Francisco
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Florida
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Boca Raton, Florida, United States, 33487
- ENT Associates of South Florida
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Port Saint Lucie, Florida, United States, 34952
- ENT and Allergy Associates of Florida
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Tampa, Florida, United States, 33619
- Florida ENT and Allergy
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Illinois
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Chicago, Illinois, United States, 60602
- Chicago Nasal and Sinus Center
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Kentucky
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Louisville, Kentucky, United States, 40220
- Advanced ENT and Allergy
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Louisiana
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Baton Rouge, Louisiana, United States, 70809
- Baton Rouge General / Sinus and Nasal Specialists of Louisiana
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North Carolina
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Winston-Salem, North Carolina, United States, 27103
- Piedmont ENT Associates
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Texas
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Fort Worth, Texas, United States, 76109
- Fort Worth ENT
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McKinney, Texas, United States, 75070
- ENT and Allergy Associates of Texas
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 18 to 85 years (inclusively).
- Willing and able to provide informed consent.
- Willing and able to comply with the subject-specific requirements outlined in the Study Protocol.
- Seeking treatment for chronic rhinitis symptoms of at least 6 months duration and willing to undergo an office-based procedure.
- Moderate to severe symptoms of rhinorrhea (rTNSS rating of 2 or 3 for rhinorrhea).
- Mild to severe symptoms of nasal congestion (rTNSS rating of 1, 2 or 3 for congestion).
- rTNSS ≥ 6.
Exclusion Criteria:
- Anatomic obstructions that in the investigator's opinion limit access to the posterior nasal passage.
- Altered anatomy of the posterior nose as a result of prior sinus or nasal surgery or injury.
- Active nasal or sinus infection.
- History of significant dry eye.
- 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.
- Have rhinitis symptoms only on a seasonal basis due to allergies.
- Known or suspected allergies or contraindications to the anesthetic agents and/or antibiotic medications to be used during the study procedure session.
- Known or suspected to be pregnant or is lactating.
- Participating in another clinical research study.
- Has any condition that predisposes to excessive bleeding.
- Is taking anticoagulants (eg, warfarin, Plavix) or 325 mg aspirin that cannot be discontinued before the procedure.
- Has previous procedure or surgery for chronic rhinitis.
- 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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: RhinAer ARC Stylus Treatment
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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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).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Mean Change of the Reflective Total Nasal Symptoms Score (rTNSS)
Time Frame: Baseline and 3 months post study procedure
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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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Participant Responder Percentage
Time Frame: Baseline and 3 months post study procedure
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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 |
Baseline and 3 months post study procedure
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3 Month - Mean Change in Mini Rhinoconjuctivitis Quality of Life Questionnaire (Mini RQLQ)
Time Frame: Baseline and 3 months post study procedure
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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
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6 Months - Mean Change in Mini Rhinoconjuctivitis Quality of Life Questionnaire (Mini RQLQ)
Time Frame: 6 Months
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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
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Number of Participants With Device Related Adverse Events
Time Frame: Baseline and 3 months post study procedure
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Evaluate profile by characterizing the type and frequency of adverse events reported at or following the study procedure an throughout the follow up period
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Baseline and 3 months post study procedure
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rTNSS Scores at 3 Months
Time Frame: 3 Months
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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
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rTNSS Score at 6 Months
Time Frame: 6 Months
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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
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rTNSS Change From Baseline at 6 Months Post Procedure
Time Frame: 6 Months
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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
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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 Aug 4:19458924251360889. doi: 10.1177/19458924251360889. Online ahead of print.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CTP1056
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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