RhinAer Stylus for Chronic Rhinitis

(RHINTRAC Trial)

No longer recruiting at 19 trial locations
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

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.14567

Who Is on the Research Team?

PS

Pablo Stolovitzky, MD

Principal Investigator

ENT of Georgia North

MT

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.
See 9 more

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.
See 10 more

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?
2Treatment groups
Active Control
Placebo Group
Group I: RhinAer TreatmentActive Control1 Intervention
Group II: Control TreatmentPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Aerin Medical

Lead Sponsor

Trials
13
Recruited
930+

Citations

Durable Relief For Your Chronic Rhinitis PatientsRhinAer Stylus provided significant symptom improvement in chronic rhinitis across allergic, non-allergic, and unknown etiologies. The RhinAer treatment showed ...
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 ...
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, ...
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.comrhinaer.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 ...
RhinAer Procedure for Treatment of Chronic Rhinitis StudyThe purpose of this study is to compare the RhinAer procedure with radiofrequency (RF) energy to sham procedure for treatment of chronic rhinitis. Detailed ...
RhinAer's Newly Published Two-year StudyData from the trial demonstrated that treatment with RhinAer to the posterior nasal nerve (PNN) is safe and provides significant, durable ...
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Terms of Service·Privacy Policy·Cookies·Security