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

Chronic Rhinitis Clinical Trial

— RELIEF  

Official title:

A Prospective, Open Label, Multi-Center Study Using the RhinAer Procedure for Treatment of Subjects Suffering With Chronic Rhinitis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04614324
• Other study ID #: CTP1056
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 5, 2020
• Est. completion date: August 30, 2024

Study information

• Verified date: July 2023
• Source: Aerin Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Post-market study to continue to evaluate the effectiveness of the RhinAer ARC Stylus for chronic rhinitis.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 140
• Est. completion date: August 30, 2024
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Rhinitis
• Rhinitis

Intervention

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).

Locations

Country	Name	City	State
Germany	HNO-ZENTRUM am Kudamm	Berlin
Germany	Universitatsklinikum Carl Gustav Carus Dresden	Dresden
Germany	Facharzt für Hals- Nasen- und Ohrenkrankheiten Allergologie Plastische Operationen	Göttingen
United States	Baton Rouge General / Sinus and Nasal Specialists of Louisiana	Baton Rouge	Louisiana
United States	ENT Associates of South Florida	Boca Raton	Florida
United States	Chicago Nasal and Sinus Center	Chicago	Illinois
United States	Fort Worth ENT	Fort Worth	Texas
United States	Arizona Desert ENT Specialists	Goodyear	Arizona
United States	Advanced ENT and Allergy	Louisville	Kentucky
United States	ENT and Allergy Associates of Texas	McKinney	Texas
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	ENT and Allergy Associates of Florida	Port Saint Lucie	Florida
United States	Sacramento ENT	Roseville	California
United States	University of California, San Francisco	San Francisco	California
United States	Florida ENT and Allergy	Tampa	Florida
United States	Piedmont ENT Associates	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Aerin Medical

Countries where clinical trial is conducted

United States,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change of the Reflective Total Nasal Symptoms Score (rTNSS)	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.; A low score indicates lower symptoms, a higher score indicates more symptoms.	Baseline and 3 months post study procedure
Secondary	30% Improvement in Reflective Total Nasal Symptoms Score (rTNSS)	The TNSS is an instrument used to collect patient self-rated severity of nasal symptoms. 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.; A low score indicates lower symptoms, a higher score indicates more symptoms.; Improvement indicates if the score at 3 months is lower than at Baseline.	Baseline and 3 months post study procedure
Secondary	Mean Change in Mini Rhinoconjuctivitis Quality of Life Questionnaire (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 and the domain scores are the mean of the questions in each domain.	Baseline and 3 months post study procedure
Secondary	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	Baseline and 3 months post study procedure

External Links

•   Clinical and Quality of Life Outcomes Following Temperature-Controlled Radiofrequency Neurolysis of the Posterior Nasal Nerve (RhinAer) for Treatment of Chronic Rhinitis