RhinAer Stylus for Chronic Rhinitis
(RHINTRAC Trial)
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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo the RhinAer procedure or a sham procedure in a single session to treat chronic rhinitis
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of nasal symptoms and adverse events
What Are the Treatments Tested in This Trial?
Interventions
- RhinAer Procedure
- Sham Procedure
Find a Clinic Near You
Who Is Running the Clinical Trial?
Aerin Medical
Lead Sponsor