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

Aerin Medical129 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

129

Conditions

Chronic Rhinitis

Interventions

RhinAer ARC StylusDEVICE

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).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (15)

Arizona Desert ENT Specialists

Goodyear, Arizona, United States

Sacramento ENT

Roseville, California, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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).

Data from ClinicalTrials.gov

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University of California, San Francisco

San Francisco, California, United States

ENT Associates of South Florida

Boca Raton, Florida, United States

ENT and Allergy Associates of Florida

Port Saint Lucie, Florida, United States

Florida ENT and Allergy

Tampa, Florida, United States

Chicago Nasal and Sinus Center

Chicago, Illinois, United States

Advanced ENT and Allergy

Louisville, Kentucky, United States

Baton Rouge General / Sinus and Nasal Specialists of Louisiana

Baton Rouge, Louisiana, United States

Piedmont ENT Associates

Winston-Salem, North Carolina, United States

...and 5 more locations

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

Time frame: 6 Months

rTNSS Change From Baseline at 6 Months Post Procedure

Time frame: 6 Months