Chronic RhinitisBIOKLEARNCT06599736
A Study of RhinAer Stylus for Treating Chronic Rhinitis
A study testing RhinAer Stylus in people with Chronic Rhinitis, run by Aerin Medical at 2 sites in United States.
Trial 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 more about this study
- Who is it for?
- Ages 22 to 85 years
- Conditions the study is for
- Chronic Rhinitis
- What is being tested?
- RhinAer Stylus
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Oct 2024to 30 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Cincinnati
Cincinnati, Ohio, 45267
Colorado ENT & Allergy
Colorado Springs, Colorado, 80923
About this study
Official title: Effect of Temperature-Controlled Radiofrequency Ablation of the Posterior Nasal Nerve on Inflammatory Biomarkers in Patients With Allergic and Nonallergic Chronic Rhinitis
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.
- Conditions
- Chronic Rhinitis
- Being tested
- RhinAer Stylus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RhinAer StylusDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: RhinAer Stylus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Nasal Secretion Inflammatory Biomarker Levels at 3 Months Following Temperature-Controlled Radiofrequency (TCRF) Treatment
Changes in nasal secretion inflammatory biomarker levels from baseline to 3 months post-procedure was evaluated in patients with allergic and nonallergic chronic rhinitis. 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), receptor potential vanilloid 1 (TRPV-1), and immunoglobulin E (IgE).
Measured: Baseline (pre-procedure) and 3 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start3 Oct 2024
- Primary completion19 Sep 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Active treatment for all subject enrolling prospectively.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aerin Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06599736
- Sponsor's protocol ID
- CTP1938
- Acronym
- BIOKLEAR
- Status last verified
- Oct 2026
- First submitted
- 2 Jul 2024
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No data collected will be shared with other researchers participating in the study.
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Temperature-Controlled Radiofrequency Ablation of the Posterior Nasal Nerve on Inflammatory Biomarkers in Patients With Allergic and Nonallergic Chronic Rhinitis
- ClinicalTrials.gov ID
- NCT06599736
- Acronym / sponsor ID
- BIOKLEAR / CTP1938
- Conditions
- Chronic Rhinitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Aerin MedicalIndustry (pharma, biotech, devices)
- Study start
- 3 Oct 2024 (actual)
- Primary completion
- 19 Sep 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Post-market study to continue to evaluate the effectiveness of the RhinAer Stylus for chronic rhinitis and the effect of treatment on inflammatory biomarkers.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Active treatment for all subject enrolling prospectively.
| Arm | Type | Receives |
|---|---|---|
| RhinAer Stylus treatment | Experimental | Device: RhinAer StylusThe 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. |
Who may qualify
- Ages
- 22 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RhinAer StylusThe 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). | Device | RhinAer Stylus treatment |
Primary outcome
Change From Baseline in Nasal Secretion Inflammatory Biomarker Levels at 3 Months Following Temperature-Controlled Radiofrequency (TCRF) Treatment
Time frame: Baseline (pre-procedure) and 3 months post-procedure
Changes in nasal secretion inflammatory biomarker levels from baseline to 3 months post-procedure was evaluated in patients with allergic and nonallergic chronic rhinitis. 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), receptor potential vanilloid 1 (TRPV-1), and immunoglobulin E (IgE).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: No. No data collected will be shared with other researchers participating in the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RhinAer Stylus in people with Chronic Rhinitis, run by Aerin Medical at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Nasal Secretion Inflammatory Biomarker Levels at 3 Months Following Temperature-Controlled Radiofrequency (TCRF) Treatment (time frame: Baseline (pre-procedure) and 3 months post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.