RhinAer Stylus for Chronic Rhinitis

(RHINTRAC Trial)

No longer recruiting at 19 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Aerin Medical

Must not be taking: Anticoagulants, Aspirin

Disqualifiers: Anatomic obstructions, Active infection, Pregnancy, others

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

Compensation: Varies

Number of Visits: 2

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new procedure, RhinAer, for individuals with chronic rhinitis, a condition causing constant runny or stuffy noses. Participants will receive either the RhinAer treatment, which uses radiofrequency energy to target nasal tissues, or a sham procedure without energy application. The goal is to determine if RhinAer is more effective than the sham in reducing symptoms. Individuals with moderate to severe runny or stuffy noses for at least six months who seek treatment may be suitable for this study. As an unphased trial, this study provides an opportunity to explore a novel treatment option for chronic rhinitis.

Do I need to stop taking my current medications for the trial?

The trial requires that you stop taking anticoagulants (blood thinners) like warfarin or Plavix, or 325 mg aspirin before the procedure. Other medications are not specifically mentioned, so it's best to discuss with the trial team.

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

Research has shown that the RhinAer procedure is safe for treating chronic rhinitis. Studies have found that patients tolerate this treatment well. In a two-year study, RhinAer proved safe and provided long-lasting benefits. Patients experienced significant improvements in their symptoms and quality of life. No serious side effects occurred, making it a reliable choice for those with chronic rhinitis. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the RhinAer procedure for chronic rhinitis because it offers a unique approach using bipolar radiofrequency energy to target the nasal cavity tissue. Unlike traditional treatments like antihistamines or nasal sprays, which primarily manage symptoms, the RhinAer procedure directly addresses the tissue overlying the posterior nasal nerve. This method could potentially provide longer-lasting relief without the need for ongoing medication. Its precise, non-surgical technique also means fewer side effects and a quicker recovery compared to more invasive procedures.

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

Research has shown that the RhinAer procedure, one of the treatments under study in this trial, effectively treats chronic rhinitis, which causes a constantly runny or stuffy nose. Specifically, studies found a 58% improvement in nasal symptoms three years after the procedure. This treatment uses radiofrequency energy to target nasal tissue, providing significant and lasting relief. Patients reported feeling better and experiencing an improved quality of life as soon as three to six months after treatment. Approximately 88% of patients noticed symptom relief lasting up to two years. These results suggest that RhinAer could be a promising option for those suffering from chronic rhinitis. ^{1 4 5 6 7}

Who Is on the Research Team?

Pablo Stolovitzky, MD

Principal Investigator

ENT of Georgia North

Mas Takashima, MD

Principal Investigator

The Sinus Center at Houston Methodist Hospital

Are You a Good Fit for This Trial?

Adults aged 18-85 with chronic rhinitis symptoms for at least 6 months, who have moderate to severe runny nose and mild to severe nasal congestion. Participants must be willing to undergo an office-based procedure and follow the study protocol. Excluded are those in other studies, with nasal infections, significant dry eye history, recent nose bleeds, prior surgeries for chronic rhinitis or conditions causing excessive bleeding.

Inclusion Criteria

Willing and able to provide informed consent.

Your nasal symptoms score is 6 or higher.

I experience mild to severe nasal congestion.

Exclusion Criteria

I have a history of severe dry eye.

I have a condition that causes me to bleed easily.

I am on blood thinners or high-dose 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

Participants undergo the RhinAer procedure or a sham procedure in a single session to treat chronic rhinitis

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of nasal symptoms and adverse events

12 months

Visits at 1 month, 3 months, 6 months, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• RhinAer Procedure
• Sham Procedure

Trial Overview

The trial is testing the RhinAer procedure that uses radiofrequency energy against a sham (fake) procedure to see which is better for treating chronic rhinitis. The real and sham procedures will be compared in participants randomly assigned to each group.

How Is the Trial Designed?

Group I: RhinAer Treatment Active Control 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 the portion of the nasal cavity mucosa overlying the region of the posterior nasal nerve (the posterior middle meatus and posterior inferior turbinate) in both nostrils treated during a single study procedure session. Each nostril will be treated at 1, 2, 3, 4 or 5 nonoverlapping positions depending on the size of the target treatment area. Treatment settings to be used are temperature 60 °C, power 4 watts, treatment time 12 seconds, and cooling time 0 seconds

Group II: Control Treatment Placebo Group 1 Intervention

The control treatment will be performed in the study clinic using the RhinAer Stylus while audible sounds that accurately simulate the Aerin Console's active treatment are produced even though RF energy is not being generated or delivered. All other aspects of the procedure will be the same as used for the active treatment, including administration of anesthetic agent(s).

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.

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 ...

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.

pmc.ncbi.nlm.nih.gov

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

Clinical and Quality of Life Outcomes Following ...

The majority of patients reported a clinically relevant improvement in QoL at 3 and 6 months postprocedure. Keywords: radiofrequency, temperature-controlled, ...

5.

rhinaer.com

rhinaer.com/hcp/

CHRONIC RHINITIS REQUIRES COMPREHENSIVE ...

In a multicenter clinical study, RhinAer Stylus provided durable and significant relief of chronic rhinitis symptoms with an 88% responder rate out to two years ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04533438

RhinAer Procedure for Treatment of Chronic Rhinitis Study

The purpose of this study is to compare the RhinAer procedure with radiofrequency (RF) energy to sham procedure for treatment of chronic rhinitis. Detailed ...

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 ...