What side effects are associated with this type of intervention?

Common treatments for chronic rhinitis include radiofrequency ablation, intranasal corticosteroids, and antihistamines. Radiofrequency ablation, such as the RhinAer ARC Stylus, typically has side effects like nasal dryness, crusting, and mild discomfort or pain at the treatment site. Intranasal corticosteroids can cause side effects such as nasal irritation, dryness, and, rarely, nosebleeds. Antihistamines may lead to drowsiness, dry mouth, and dizziness. Patients should discuss these potential side effects with their healthcare provider to determine the best treatment option for their condition.

What prior FDA approvals exist?

The FDA has approved various treatments for chronic rhinitis, including medications like glucocorticoid nasal sprays, antihistamines, and leukotriene receptor antagonists such as montelukast. While specific FDA approvals for radiofrequency ablation devices like the RhinAer ARC Stylus are not detailed, this method represents a minimally invasive approach aimed at reducing nasal tissue to alleviate symptoms. Other non-pharmacological treatments, such as sublingual immunotherapy (SLIT) for allergic rhinitis, have also been approved and are used to manage chronic symptoms.

What other types of research exist?

Promising novel alternatives to the RhinAer ARC Stylus for chronic rhinitis treatment include: 1) Cryotherapy, which involves freezing the posterior nasal nerve to reduce symptoms, and 2) ClariFix, a minimally invasive device that uses cryotherapy to target the nerves causing rhinitis. Both methods have shown effectiveness in reducing symptoms of chronic rhinitis.

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N/A

RhinAer ARC Stylus for Chronic Rhinitis (RELIEF Trial)

N/A

Waitlist Available

Research Sponsored by Aerin Medical

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Moderate to severe symptoms of rhinorrhea (rTNSS rating of 2 or 3 for rhinorrhea)

Age 18 to 85 years (inclusively).

Must not have

Is taking anticoagulants (eg, warfarin, Plavix) or 325 mg aspirin that cannot be discontinued before the procedure

History of any of the following: chronic epistaxis, documented episodes of significant nose bleeds in the past 3 months, rhinitis medicamentosa, head or neck irradiation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed here, potential risks may include discomfort from the procedure itself and typical surgical risks such as infection or bleeding.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have moderate to severe runny nose symptoms.

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I am between 18 and 85 years old.

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I experience mild to severe nasal congestion.

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I have moderate to severe runny nose symptoms.

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I am between 18 and 85 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have had chronic nosebleeds, significant nose bleeds in the last 3 months, medication-induced nasal issues, or radiation therapy to the head or neck.

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I have a condition that causes me to bleed easily.

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I have a history of severe dry eye.

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My nose's structure is changed due to past surgery or injury.

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I currently have a nasal or sinus infection.

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I have had surgery for long-term nose inflammation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mean Change of the Reflective Total Nasal Symptoms Score (rTNSS)

Secondary study objectives

3 Month - Mean Change in Mini Rhinoconjuctivitis Quality of Life Questionnaire (Mini RQLQ)

6 Months - Mean Change in Mini Rhinoconjuctivitis Quality of Life Questionnaire (Mini RQLQ)

Number of Participants With Device Related Adverse Events

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: RhinAer ARC 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.

0 / 12Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The RhinAer ARC Stylus treats Chronic Rhinitis by using radiofrequency ablation to reduce the size of the nasal tissue, thereby decreasing nasal congestion and improving airflow. This method targets the underlying tissue to provide long-term relief. Nasal corticosteroids work by reducing inflammation in the nasal passages, which helps to alleviate symptoms such as congestion, sneezing, and runny nose. Antihistamines block histamine receptors to reduce allergic reactions and associated symptoms. Immunotherapy, including sublingual and subcutaneous forms, gradually desensitizes the immune system to specific allergens, reducing the severity of allergic responses over time. These treatments are crucial for Chronic Rhinitis patients as they address both the symptoms and underlying causes, improving quality of life and reducing the frequency and severity of flare-ups.