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

Completed · Not applicable

Conditions studied: Chronic Rhinitis

In brief

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

Key facts

Study ID

NCT04614324

Run by

Aerin Medical

People needed

129

Starts

2020-10-05

Expected to finish

2024-12-20

Last updated by the study team

2025-08-28

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Arizona Desert ENT Specialists — Goodyear, Arizona, United States
• Sacramento ENT — Roseville, California, United States
• 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
• Fort Worth ENT — Fort Worth, Texas, United States
• ENT and Allergy Associates of Texas — McKinney, Texas, United States
• HNO-ZENTRUM am Kudamm — Berlin, Germany
• Universitatsklinikum Carl Gustav Carus Dresden — Dresden, Germany
• Facharzt für Hals- Nasen- und Ohrenkrankheiten Allergologie Plastische Operationen — Göttingen, Germany

Full record on ClinicalTrials.gov

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