RhinAer Stylus for Hay Fever

(BIOKLEAR Trial)

Recruiting at 1 trial location

Overseen By Tien 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 Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 1 day

25 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the RhinAer Stylus, a device designed to help people with chronic rhinitis, a condition characterized by a persistently runny or stuffy nose. Researchers aim to evaluate the device's effectiveness and its impact on certain inflammation-related markers in the body. Participants will receive treatment with a special device that uses controlled energy to target problem areas in the nose. This trial may suit individuals who have experienced long-term nasal issues, such as a constant runny or stuffy nose, for at least a year and seek a new treatment option. As an unphased trial, this study provides an opportunity to explore a new treatment for chronic rhinitis.

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 prior data suggests that the RhinAer Stylus is safe for treating chronic rhinitis?

Research has shown that the RhinAer Stylus safely treats chronic rhinitis. Studies found that targeting a specific nerve in the nose with the RhinAer Stylus provides long-lasting symptom relief. One study found significant symptom improvement within three months of treatment, with continued or enhanced improvement over six months. The RhinAer Stylus has already received approval for use, supporting its safety. No serious safety issues have been reported in studies so far. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for hay fever, which often involve medications like antihistamines and nasal corticosteroids, the RhinAer Stylus offers a novel approach by using bipolar radiofrequency energy. This energy is delivered via a handheld device directly to the nasal tissue, targeting the posterior nasal nerve, which plays a significant role in nasal symptoms. Researchers are excited about RhinAer because it provides a minimally invasive option that may offer long-lasting relief without the need for ongoing medication.

What evidence suggests that the RhinAer Stylus is effective for chronic rhinitis?

Research has shown that the RhinAer Stylus, which participants in this trial will receive, effectively treats chronic rhinitis, a condition causing a stuffy or runny nose. Studies have found a significant improvement in patients' nasal symptoms, with a 58% reduction in total nasal symptom scores even three years after treatment. This indicates that many experienced much less trouble with their nasal symptoms for an extended period. The RhinAer Stylus uses radiofrequency energy to target tissue in the nose, helping to reduce symptoms. These results suggest that the treatment may provide lasting relief for people with chronic rhinitis, regardless of whether allergies cause it. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: RhinAer Stylus treatment Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Aerin Medical

Lead Sponsor

Trials

13

Recruited

930+

Citations

1. rhinaer.com rhinaer.com/hcp/clinical-outcomes/

Durable Relief For Your Chronic Rhinitis Patients RhinAer Stylus provided significant symptom improvement in chronic rhinitis across allergic, non-allergic, and unknown etiologies. The RhinAer treatment showed ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06599736

A Study of RhinAer Stylus for Treating 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.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9158436/

Long-term Outcomes Following Temperature-Controlled ... Patients with allergic, nonallergic, and rhinitis of unknown origin exhibited a durable improvement in symptoms through 12 months and 24 months, ...

4. clinicaltrial.be clinicaltrial.be/fr/details/2772?per_page=100&only_recruiting=0&only_eligible=0&only_active=0

A Study of RhinAer ARC Stylus for Treating Chronic Rhinit... The RhinAer Stylus is a disposable handheld device capable of delivering bipolar radiofrequency energy to tissue when connected to the Aerin ...

5. aerinmedical.com aerinmedical.com/company/news-and-media/three-year-study-confirms-lasting-chronic-rhinitis-symptom-relief-and-quality-of-life-improvements-with-rhinaer/

Three-Year Study Confirms Lasting Chronic Rhinitis ... Patients experienced a 58% improvement in total nasal symptom scores (rTNSS) at three years, consistent with the strong outcomes observed at ...

6. rhinaer.com rhinaer.com/hcp/

CHRONIC RHINITIS REQUIRES COMPREHENSIVE ... “Treatment of the PNN using RhinAer Stylus has been shown to be an effective, patient-friendly option to treat both chronic allergic and non-allergic rhinitis.

7. aerinmedical.com aerinmedical.com/company-news/aerin-medical-rhinaer-demonstrates-long-term-safety-and-efficacy-for-treatment-of-chronic-rhinitis-in-newly-published-two-year-study/

RhinAer's Newly Published Two-year Study Data from the trial demonstrated that treatment with RhinAer to the posterior nasal nerve (PNN) is safe and provides significant, durable ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9548948/

Clinical and Quality of Life Outcomes Following ... TCRF neurolysis of the PNN was safe and resulted in a significant reduction in rhinitis symptom burden at 3 months that was sustained/improved through 6 months.