A Study of RhinAer Stylus for Treating Chronic Rhinitis

NCT06599736 | Active Not Recruiting FDA Device

• 1 other identifier: CTP1938
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Chronic Rhinitis

Keywords

ENT; Chronic rhinitis; Allergic rhinitis; Non-allergic rhinitis

Outcome Measures

Primary Outcomes (1)

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

  Change from baseline in expression of type-2 inflammatory cytokine markers in nasal mucus samples at 3 months post-procedure

  Baseline and 3 months post study procedure

Secondary Outcomes (6)

• The change in cough and post-nasal drip symptoms

  From baseline to 6 months post-procedure

• The change in nasal symptoms of chronic rhinitis

  From baseline to 6 months post-procedure

• Change in SNOT-22 score

  From baseline to 6 months post-procedure

• Evaluate the impact of the RhinAer treatment in subjects with migraine-related symptoms

  From baseline to 6 months post-procedure

• Evaluate medication usage in chronic rhinitis patients

  From baseline to completion of study, an average of 6 months

Other Outcomes (1)

• Evaluate the occurrence of any device- or procedure-related adverse events

  From baseline to completion of study, an average of 6 months

Study Arms (1)

RhinAer Stylus treatment

EXPERIMENTAL

The RhinAer procedure will be performed in the study clinic using the RhinAer Stylus and Aerin Console. The RhinAer Stylus is a disposable handheld device capable of delivering bipolar radiofrequency energy to tissue when connected to the Aerin Console radiofrequency generating device. Participants will have both nostrils treated in the portion of the nasal cavity mucosa overlying the region of the posterior nasal nerve.

Device: RhinAer Stylus

Interventions

RhinAer Stylus DEVICE

The RhinAer procedure incorporates use of the RhinAer Stylus (Model FG1393, CAT1394), which is a 510(k) cleared (FDA - K221907) disposable handheld device capable of delivering bipolar radiofrequency energy to tissue. The Aerin Console (Model FG226) RF generator with temperature control capable of delivering very low doses of energy is also cleared for use in the US (FDA - K162810).

RhinAer Stylus treatment

Eligibility Criteria

• Age: 22 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.'
• Has had previous procedure or surgery for chronic rhinitis (e.g., PNN ablation).
• Has had a nasal or sinus surgical procedure in the past six (6) months.
• Currently participating in another clinical research study or has participated in an interventional study within the past 3 months.
• Has a planned adjunctive procedure at the time of the study procedure or within the 6-month study follow-up period
• Other medical conditions which in the opinion of the investigator would predispose the patient to poor wound healing, increased surgical risk, or poor compliance with the requirements of the study.

Sponsors & Collaborators

• Aerin Medical: lead

Study Sites (2)

Colorado ENT & Allergy

Colorado Springs, Colorado, 80923, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

MeSH Terms

Conditions

Rhinitis, Allergic; Common Cold

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Respiratory Tract Infections; Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Active treatment for all subject enrolling prospectively.

Study Record Dates

• First Submitted: July 2, 2024
• First Posted: September 19, 2024
• Study Start: October 3, 2024
• Primary Completion: November 12, 2025
• Study Completion: March 1, 2026
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)