Active — Not RecruitingNot Applicable

A Study of RhinAer Stylus for Treating Chronic Rhinitis

United States25 participantsStarted 2024-10-03

Plain-language summary

Post-market study to continue to evaluate the effectiveness of the RhinAer Stylus for chronic rhinitis and the effect of treatment on inflammatory biomarkers.

Who can participate

Age range22 Years – 85 Years

SexALL

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Inclusion criteria

✓. Age 22 to 85 years (inclusively).
✓. Willing and able to provide informed consent.
✓. Willing and able to comply with the patient-specific requirements outlined in the study protocol.
✓. Presenting to the ENT office seeking evaluation and/or treatment for chronic rhinitis (allergic or nonallergic) of at least 12 months duration
✓. Willing to undergo the RhinAer procedure
✓. Has a baseline rTNSS symptom score of ≥6 at time of screening
✓. If on anticoagulation therapy, anticoagulant medications can be withheld during the perioperative period (at least 3-day window pre- and post-procedure).
✓. Has been diagnosed with either allergic or non-allergic chronic rhinitis and meet the following criteria:

Exclusion criteria

✕. Anatomic obstructions in the nasal passage(s) that in the investigator's opinion limits access to the posterior nasal nerve treatment area.
✕. Has seasonal rhinitis symptoms.
✕. Current or recent use of biologic therapy within past 3 months.
✕. History of chronic epistaxis or has had episodes of significant nose bleeds in the past 3 months.
✕. Known or suspected allergies or contraindications to the anesthetic agents and/or antibiotic medications to be used during the study procedure.
✕. Known or suspected to be pregnant or is lactating.
✕. Has any condition resulting in a predisposition to excessive bleeding (e.g., hereditary hemorrhagic telangiectasia \[HHT\]).
✕. Has diagnosis of rhinitis medicamentosa, an active nasal or sinus infection or has a history of 'dry eye.'

What they're measuring

Change in expression of nasal mucosal inflammatory markers in allergic and nonallergic chronic rhinitis patients

Timeframe: Baseline and 3 months post study procedure

Trial details

NCT IDNCT06599736

SponsorAerin Medical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-11-12

View on ClinicalTrials.gov More Chronic Rhinitis trials