ClinicalTrials.gg
CompletedNCT06599736BIOKLEARUpdated Nov 9, 2026

A Study of RhinAer Stylus for Treating Chronic Rhinitis

An interventional study of RhinAer Stylus in Chronic Rhinitis, sponsored by Aerin Medical. Completed at 2 sites in United States. Open to participants aged 22 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-11-09.

Sponsored by Aerin Medical · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Sep 2025, 1 year 1 month ago, and no results have been posted to the registry.
Updated Nov 9, 2026Now CompletedPrimary outcomes revised+3 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Not applicable
Ages
22 Years to 85 Years
Sex
All
01

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.

Read the detailed 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.

02

Conditions studied

  • Chronic Rhinitis

Browse trials for

03

In context

Rhinitis

246 studies on the registry are indexed under Rhinitis; 22 are open to participants now.

This study's enrollment of 24 is below the median of 80 across 187 interventional studies indexed under Rhinitis.

Browse Rhinitis studies →

Lead sponsor

Aerin Medical is the lead sponsor of 15 studies on the registry; 1 is open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 7 (88%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
22 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age 22 to 85 years (inclusively).
  2. Willing and able to provide .
  3. Willing and able to comply with the patient-specific requirements outlined in the study protocol.
  4. Presenting to the ENT office seeking evaluation and/or treatment for chronic rhinitis (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 the perioperative period (at least 3-day window pre- and post-procedure).
  8. 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.

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 criteria

Exclusion Criteria:

  1. Anatomic obstructions in the nasal passage(s) that in the investigator's opinion limits 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 the past 3 months.
  5. Known or suspected allergies or to the anesthetic agents and/or antibiotic 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 a history 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 an interventional 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 predispose the patient to poor wound healing, increased surgical risk, or poor compliance with the requirements of the study.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    RhinAer Stylus treatment

    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

  • DeviceRhinAer Stylus

    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).

06

What researchers measure

Primary outcomes

  1. Change From Baseline in Nasal Secretion Inflammatory Biomarker Levels at 3 Months Following Temperature-Controlled Radiofrequency (TCRF) Treatment

    Changes from baseline to 3 months post-procedure in nasal secretion inflammatory biomarker levels were evaluated in patients with allergic and nonallergic chronic rhinitis by assessing the change from baseline in mean fluorescence intensity (MFI) for each biomarker. The following biomarkers were assessed: epidermal growth factor (EGF), interferon-gamma (IFNγ), interleukins (IL-1β, IL-4, IL-5, IL-6, IL-8, IL-10, IL-13, IL-17A, IL-17F, IL-22, IL-25), tumor necrosis factor-alpha (TNFα), transient receptor potential vanilloid 1 (TRPV-1), and immunoglobulin E (IgE).

    Time frame: Baseline (pre-procedure) and 3 months post-procedure

07

Study locations

2 sites
  • Colorado ENT & Allergy
    Colorado Springs, Colorado 80923, United States
  • University of Cincinnati
    Cincinnati, Ohio 45267, United States
08

References and documents

Individual participant data

Plan to share: No — No data collected will be shared with other researchers participating in the study.

No publications or documents are linked to this record.

09

Updates

2 registry updates since Sep 25, 2026
Status
Active, not recruiting→Completed
changed Nov 2, 2026
Primary completion
Nov 12, 2025→Sep 19, 2025
Nov 2, 2026
Study completion
Mar 2026→Nov 30, 2025 (actual)
Nov 2, 2026
Enrollment
25 (estimated)→24 (actual)
Nov 2, 2026
Primary outcomes
Revised in 2 updates
What changed on Nov 2, 2026
  • ChangedBefore Change in expression of nasal mucosal inflammatory markers in allergic and nonallergic chronic rhinitis patientsNow Change From Baseline in Nasal Secretion Inflammatory Biomarker Levels at 3 Months Following Temperature-Controlled Radiofrequency (TCRF) TreatmentTime frame: Baseline and 3 months post study procedure → Baseline (pre-procedure) and 3 months post-procedure
What changed on Nov 9, 2026
  • DescriptionChange From Baseline in Nasal Secretion Inflammatory Biomarker Levels at 3 Months Following Temperature-Controlled Radiofrequency (TCRF) Treatment: how it is measured was reworded
across 2 updates, Nov 2, 2026 – Nov 9, 2026
Secondary outcomes
7 removed
What changed in the outcomes
  • RemovedThe change in cough and post-nasal drip symptomsTime frame: From baseline to 6 months post-procedure
  • RemovedThe change in nasal symptoms of chronic rhinitisTime frame: From baseline to 6 months post-procedure
  • RemovedChange in SNOT-22 scoreTime frame: From baseline to 6 months post-procedure
  • RemovedEvaluate the impact of the RhinAer treatment in subjects with migraine-related symptomsTime frame: From baseline to 6 months post-procedure
  • RemovedEvaluate medication usage in chronic rhinitis patientsTime frame: From baseline to completion of study, an average of 6 months
  • RemovedEvaluate patient reported pain outcomes related to the study procedureTime frame: Completed following the study procedure during treatment visit
  • Removedother outcomeEvaluate the occurrence of any device- or procedure-related adverse eventsTime frame: From baseline to completion of study, an average of 6 months
Nov 2, 2026
Show all 2 updates
  1. Nov 9, 2026
    Primary outcomes 1 description edited
    What changed in the outcomes
    • DescriptionChange From Baseline in Nasal Secretion Inflammatory Biomarker Levels at 3 Months Following Temperature-Controlled Radiofrequency (TCRF) Treatment: how it is measured was reworded
    + 1 other change: verification date
  2. Nov 2, 2026
    Active, not recruiting→Completed
    Primary completion Nov 12, 2025→Sep 19, 2025
    Study completion Mar 2026→Nov 30, 2025 (now actual)
    Enrollment 25 (estimated)→24 (actual)
    Primary outcomes 1 edited
    What changed in the outcomes
    • ChangedBefore Change in expression of nasal mucosal inflammatory markers in allergic and nonallergic chronic rhinitis patientsNow Change From Baseline in Nasal Secretion Inflammatory Biomarker Levels at 3 Months Following Temperature-Controlled Radiofrequency (TCRF) TreatmentTime frame: Baseline and 3 months post study procedure → Baseline (pre-procedure) and 3 months post-procedure
    Secondary outcomes 7 removed
    What changed in the outcomes
    • RemovedThe change in cough and post-nasal drip symptomsTime frame: From baseline to 6 months post-procedure
    • RemovedThe change in nasal symptoms of chronic rhinitisTime frame: From baseline to 6 months post-procedure
    • RemovedChange in SNOT-22 scoreTime frame: From baseline to 6 months post-procedure
    • RemovedEvaluate the impact of the RhinAer treatment in subjects with migraine-related symptomsTime frame: From baseline to 6 months post-procedure
    • RemovedEvaluate medication usage in chronic rhinitis patientsTime frame: From baseline to completion of study, an average of 6 months
    • RemovedEvaluate patient reported pain outcomes related to the study procedureTime frame: Completed following the study procedure during treatment visit
    • Removedother outcomeEvaluate the occurrence of any device- or procedure-related adverse eventsTime frame: From baseline to completion of study, an average of 6 months
    + 3 other changes: verification date, conditions and index terms

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06599736
Lead sponsor
Aerin Medical
Responsible party
Sponsor
First posted
Sep 19, 2024
Start date
Oct 3, 2024
Primary completion
Sep 19, 2025
Completion
Nov 30, 2025
Last update
Nov 9, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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