A Study of RhinAer Stylus for Treating Chronic Rhinitis

Last updated: April 4, 2025
Sponsor: Aerin Medical
Overall Status: Active - Recruiting

Phase

N/A

Condition

Common Cold

Allergy

Nasal Obstruction

Treatment

RhinAer Stylus

Clinical Study ID

NCT06599736
CTP1938
  • Ages 22-85
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age 22 to 85 years (inclusively).

  2. Willing and able to provide informed consent.

  3. Willing and able to comply with the patient-specific requirements outlined in thestudy protocol.

  4. Presenting to the ENT office seeking evaluation and/or treatment for chronicrhinitis (allergic or nonallergic) of at least 12 months duration

  5. Willing to undergo the RhinAer procedure

  6. Has a baseline rTNSS symptom score of ≥6 at time of screening

  7. If on anticoagulation therapy, anticoagulant medications can be withheld during theperioperative period (at least 3-day window pre- and post-procedure).

  8. Has been diagnosed with either allergic or non-allergic chronic rhinitis and meetthe following criteria:

  • a. Allergic rhinitis: diagnosed with perennial (non-seasonal) allergic rhinitisand has demonstrated sensitization to specific allergens through skin pricktesting, specific IgE blood testing, or other allergy testing methods,confirming the allergic nature of their rhinitis within the past 24 months.

OR

-b. Nonallergic rhinitis: diagnosed with nonallergic rhinitis with demonstration of a negative skin prick testing, specific IgE blood testing, or other allergy testing methods, confirming the nonallergic nature of their rhinitis within the past 24 months.

Exclusion

Exclusion Criteria:

  1. Anatomic obstructions in the nasal passage(s) that in the investigator's opinionlimits access to the posterior nasal nerve treatment area.

  2. Has seasonal rhinitis symptoms.

  3. Current or recent use of biologic therapy within past 3 months.

  4. History of chronic epistaxis or has had episodes of significant nose bleeds in thepast 3 months.

  5. Known or suspected allergies or contraindications to the anesthetic agents and/orantibiotic medications to be used during the study procedure.

  6. Known or suspected to be pregnant or is lactating.

  7. Has any condition resulting in a predisposition to excessive bleeding (e.g.,hereditary hemorrhagic telangiectasia [HHT]).

  8. Has diagnosis of rhinitis medicamentosa, an active nasal or sinus infection or has ahistory of 'dry eye.'

  9. Has had previous procedure or surgery for chronic rhinitis (e.g., PNN ablation).

  10. Has had a nasal or sinus surgical procedure in the past six (6) months.

  11. Currently participating in another clinical research study or has participated in aninterventional study within the past 3 months.

  12. Has a planned adjunctive procedure at the time of the study procedure or within the 6-month study follow-up period

  13. Other medical conditions which in the opinion of the investigator would predisposethe patient to poor wound healing, increased surgical risk, or poor compliance withthe requirements of the study.

Study Design

Total Participants: 25
Treatment Group(s): 1
Primary Treatment: RhinAer Stylus
Phase:
Study Start date:
October 03, 2024
Estimated Completion Date:
November 30, 2025

Study Description

Prospective, Open Label, Multicenter Study of the Aerin Medical RhinAer® Stylus for Chronic Rhinitis to continue to evaluate the effectiveness of the RhinAer® Stylus for treating the posterior nasal nerve area to improve symptoms in adults diagnosed with chronic rhinitis.

Connect with a study center

  • Colorado ENT & Allergy

    Colorado Springs, Colorado 80923
    United States

    Active - Recruiting

  • University of Cincinnati

    Cincinnati, Ohio 45267
    United States

    Active - Recruiting

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