Clinical trial NCT04614324: A Study of RhinAer ARC Stylus for Treating Chronic Rhinitis (RELIEF)
Official title: A Prospective, Open Label, Multi-Center Study Using the RhinAer Procedure for Treatment of Subjects Suffering With Chronic Rhinitis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Chronic Rhinitis
Lead sponsor: Aerin Medical
Sponsor class: INDUSTRY
First posted: 2020-11-04
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Active treatment for all subject enrolling prospectively
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mean Change of the Reflective Total Nasal Symptoms Score (rTNSS)
timeFrame: Baseline and 3 months post study procedure
Secondary outcomes:
measure: Participant Responder Percentage
timeFrame: Baseline and 3 months post study procedure
measure: 3 Month - Mean Change in Mini Rhinoconjuctivitis Quality of Life Questionnaire (Mini RQLQ)
timeFrame: Baseline and 3 months post study procedure
measure: 6 Months - Mean Change in Mini Rhinoconjuctivitis Quality of Life Questionnaire (Mini RQLQ)
timeFrame: 6 Months
measure: Number of Participants With Device Related Adverse Events
timeFrame: Baseline and 3 months post study procedure
measure: rTNSS Scores at 3 Months
timeFrame: 3 Months
measure: rTNSS Score at 6 Months
timeFrame: 6 Months
measure: rTNSS Change From Baseline at 6 Months Post Procedure
timeFrame: 6 Months
Other outcomes:
Locations:
city: Goodyear
country: United States
facility: Arizona Desert ENT Specialists
state: Arizona
city: Roseville
country: United States
facility: Sacramento ENT
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Boca Raton
country: United States
facility: ENT Associates of South Florida
state: Florida
city: Port Saint Lucie
country: United States
facility: ENT and Allergy Associates of Florida
state: Florida
city: Tampa
country: United States
facility: Florida ENT and Allergy
state: Florida
city: Chicago
country: United States
facility: Chicago Nasal and Sinus Center
state: Illinois
city: Louisville
country: United States
facility: Advanced ENT and Allergy
state: Kentucky
city: Baton Rouge
country: United States
facility: Baton Rouge General / Sinus and Nasal Specialists of Louisiana
state: Louisiana
city: Winston-Salem
country: United States
facility: Piedmont ENT Associates
state: North Carolina
city: Fort Worth
country: United States
facility: Fort Worth ENT
state: Texas
city: McKinney
country: United States
facility: ENT and Allergy Associates of Texas
state: Texas
city: Berlin
country: Germany
facility: HNO-ZENTRUM am Kudamm
city: Dresden
country: Germany
facility: Universitatsklinikum Carl Gustav Carus Dresden
city: Göttingen
country: Germany
facility: Facharzt für Hals- Nasen- und Ohrenkrankheiten Allergologie Plastische Operationen
Study officials:
References:
citation: 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.
citation: 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.