RhinAer Procedure for Treatment of Chronic Rhinitis Study

Completed · Not applicable · Has a placebo group

Conditions studied: Chronic Rhinitis

In brief

The purpose of this study is to compare the RhinAer procedure with radiofrequency (RF) energy to sham procedure for treatment of chronic rhinitis.

Key facts

Study ID

NCT04533438

Run by

Aerin Medical

People needed

116

Starts

2020-07-31

Expected to finish

2024-12-30

Last updated by the study team

2025-05-02

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

• Sacramento ENT (DaVinci Research) — Roseville, California, United States
• Breathe Clear Institute — Torrance, California, United States
• ENT and Allergy Associates of Florida — Plantation, Florida, United States
• University of South Florida — Tampa, Florida, United States
• Piedmont ENT — Atlanta, Georgia, United States
• Rush University — Chicago, Illinois, United States
• Madison ENT — New York, New York, United States
• University of Cincinnati College of Medicine — Cincinnati, Ohio, United States
• Vanderbilt Asthma, Sinus & Allergy Program — Nashville, Tennessee, United States
• Texas Healthcare — Fort Worth, Texas, United States
• Fredericksburg ENT — Fredericksburg, Texas, United States
• ENT Associates of Texas (ENTtex) — McKinney, Texas, United States
• Ogden Clinic — Ogden, Utah, United States

Full record on ClinicalTrials.gov

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