RhinAer ARC Stylus for Chronic Rhinitis

(RELIEF Trial)

Recruiting at 17 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Aerin Medical

Must not be taking: Anticoagulants, Aspirin

Disqualifiers: Nasal obstructions, Dry eye, others

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

Compensation: Varies

Number of Visits: 3

Duration: 1 day

129 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is studying a device called the RhinAer ARC Stylus, which is used to treat adults with chronic rhinitis. The device works by targeting nerves in the back of the nose to help reduce symptoms like a runny or stuffy nose.

Will I have to stop taking my current medications?

If you are taking anticoagulants (blood thinners) like warfarin or Plavix, or 325 mg aspirin, you will need to stop them before the procedure. The trial does not specify about other medications.

How does the RhinAer ARC Stylus treatment for chronic rhinitis differ from other treatments?

The RhinAer ARC Stylus treatment for chronic rhinitis is unique because it likely involves a novel mechanism or administration method compared to standard treatments like intranasal corticosteroids or antihistamines, which are commonly used for allergic rhinitis. This treatment may offer a different approach, potentially improving symptom control for patients who do not respond well to existing therapies. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

Adults aged 18-85 with moderate to severe runny nose and nasal congestion due to chronic rhinitis, lasting at least 6 months, who are seeking treatment and willing to undergo an office procedure. Excludes those on certain blood thinners or aspirin, with altered nasal anatomy, active infections, poor wound healing risk factors, previous chronic rhinitis surgery or procedures.

Inclusion Criteria

You are willing and able to comply with the requirements of the study.

I have moderate to severe runny nose symptoms.

I experience mild to severe nasal congestion.

Exclusion Criteria

Known or suspected allergies or contraindications to the anesthetic agents and/or antibiotic medications to be used during the study procedure session

Known or suspected to be pregnant or is lactating

I am on blood thinners like warfarin or aspirin that I can't stop before a procedure.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

The RhinAer procedure is performed 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 safety and effectiveness after treatment, with assessments at 3 and 6 months

6 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• RhinAer ARC Stylus

Trial Overview The effectiveness of the RhinAer ARC Stylus is being evaluated for treating symptoms of chronic rhinitis in adults. This post-market study aims to confirm how well it works following its initial approval.

How Is the Trial Designed?

Group I: RhinAer ARC 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. United States pubmed.ncbi.nlm.nih.gov

Effect of the addition of montelukast to fluticasone propionate for the treatment of perennial allergic rhinitis. [2022]

2. Mexico pubmed.ncbi.nlm.nih.gov

[Allergic Rhinitis and its Impact on Asthma (ARIA) in Latin America]. [2015]

3. England pubmed.ncbi.nlm.nih.gov

MASK-rhinitis, a single tool for integrated care pathways in allergic rhinitis. [2015]

4. United States pubmed.ncbi.nlm.nih.gov

Characterizing rhinitis subtypes. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Intranasal corticosteroid and antihistamine combinations in the treatment of allergic rhinitis: the role of the novel formulation olopatadine/mometasone furoate. [2023]