RhinAer Stylus for Hay Fever
(BIOKLEAR Trial)

Recruiting at 1 trial location

Overseen ByTien Dang

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Aerin Medical

Must not be taking: Biologic therapy

Disqualifiers: Nasal obstructions, Seasonal rhinitis, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are on anticoagulation therapy, you will need to stop these medications at least 3 days before and after the procedure.

What data supports the effectiveness of the RhinAer Stylus treatment for hay fever?

While there is no direct data on RhinAer Stylus for hay fever, treatments for allergic rhinitis, which is similar to hay fever, often include antihistamines and leukotriene receptor antagonists. These have been shown to reduce symptoms like sneezing and nasal congestion, suggesting that similar treatments may be effective for hay fever.¹ ² ³ ⁴ ⁵

How does the RhinAer Stylus treatment for hay fever differ from other treatments?

The RhinAer Stylus treatment is unique because it likely involves a novel mechanism or method of administration compared to traditional hay fever treatments like antihistamines or nasal sprays, although specific details about its uniqueness are not provided in the available research.² ⁶ ⁷ ⁸ ⁹

What is the purpose of this trial?

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

This trial is for adults aged 22-85 with chronic rhinitis (allergic or nonallergic) lasting at least a year. Participants must consent to the study, follow its protocol, and have a moderate symptom score. Those with allergic rhinitis need recent proof of allergen sensitivity; those with nonallergic rhinitis require confirmation of their condition's nature.

Inclusion Criteria

I have been diagnosed with nonallergic rhinitis, confirmed by negative allergy tests in the last 2 years.

I am between 22 and 85 years old.

I am willing and able to agree to participate in the study.

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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo the RhinAer procedure using the RhinAer Stylus and Aerin Console to treat the posterior nasal nerve area

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in inflammatory markers, nasal symptoms, and adverse events

6 months

Multiple visits (in-person and virtual) at 3 and 6 months post-procedure

Treatment Details

Interventions

RhinAer Stylus

Trial Overview The RhinAer Stylus procedure is being evaluated for its effectiveness in treating chronic rhinitis. The study also looks at how this treatment affects inflammatory markers associated with the condition.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: RhinAer Stylus treatmentExperimental Treatment1 Intervention

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.