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

Launched by AERIN MEDICAL · Nov 2, 2020

Keywords

ClinConnect Summary

The RELIEF trial is a study investigating the RhinAer ARC Stylus, a device designed to treat chronic rhinitis, which is a condition that causes long-lasting nasal symptoms like a runny nose and congestion. This study is currently active and is looking to evaluate how effective this treatment is for people who have been experiencing these symptoms for at least six months. To be eligible, participants need to be between 18 and 85 years old and should have moderate to severe nasal symptoms. They should be willing to undergo a procedure in a doctor's office, and they must provide consent to participate.

If someone joins this study, they can expect to receive treatment with the RhinAer ARC Stylus and will be monitored for how well it works for their symptoms. However, there are certain criteria that would exclude someone from participating, such as having had previous surgeries on their nose, certain infections, or being pregnant. Overall, this trial aims to help improve treatment options for individuals suffering from chronic rhinitis, making it an important step in understanding how to better manage this condition.

Gender

ALL

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.