RhinAer ARC Stylus for Chronic Rhinitis
(RELIEF Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines the effectiveness of the RhinAer ARC Stylus for individuals with chronic rhinitis, a condition characterized by a persistently runny or congested nose. The treatment uses a small device to apply energy to nasal tissue, aiming to alleviate these symptoms. Individuals with moderate to severe nasal issues, such as a runny or stuffy nose for at least six months, who are open to a simple office procedure, might be suitable candidates. As an unphased trial, this study provides an opportunity to explore a new treatment option for managing chronic rhinitis symptoms.
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.
What prior data suggests that the RhinAer ARC Stylus is safe for treating chronic rhinitis?
Research shows that the RhinAer ARC Stylus is a promising treatment for chronic rhinitis, a long-term nasal condition. Studies have found that this device works well and is generally easy for patients to tolerate. It uses radio waves to treat a specific part of the nose, significantly relieving symptoms like a runny nose, congestion, and sneezing.
Regarding safety, previous studies indicate that patients usually handle the treatment well, with no major safety issues reported. As this is a post-market study, the device has already been approved for use, suggesting confidence in its safety. Overall, the RhinAer ARC Stylus appears to be a safe and effective option for managing chronic rhinitis.12345Why are researchers excited about this trial?
Unlike other treatments for chronic rhinitis, which often rely on medications like antihistamines or nasal sprays, the RhinAer ARC Stylus offers a novel approach using bipolar radiofrequency energy. This technology targets the posterior nasal nerve area, potentially providing relief by reducing nerve activity linked to rhinitis symptoms. Researchers are excited about this treatment because it could reduce the need for ongoing medication use and provide longer-lasting symptom control with a minimally invasive procedure.
What evidence suggests that the RhinAer ARC Stylus is effective for chronic rhinitis?
Research has shown that the RhinAer ARC Stylus, which participants in this trial will receive, effectively treats long-term nasal inflammation, known as chronic rhinitis. One study found that 88% of patients experienced significant and lasting symptom relief for up to two years. This treatment uses radio waves to target nasal tissues, reducing symptoms like a runny or stuffy nose. Another study confirmed that a single RhinAer procedure can provide meaningful relief for up to three years. These findings suggest that the RhinAer ARC Stylus offers a long-lasting solution for people with chronic rhinitis, regardless of the cause.13678
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
The RhinAer procedure is performed using the RhinAer Stylus and Aerin Console to treat the posterior nasal nerve area
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments at 3 and 6 months
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?
1
Treatment groups
Experimental Treatment
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Aerin Medical
Lead Sponsor
Citations
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 ...
Long-term Outcomes Following Temperature-Controlled ...
Temperature-controlled radiofrequency neurolysis results in a significant and durable reduction in the symptom burden of chronic rhinitis.
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 ...
4.
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 ...
“We now have three-year data showing that a single in-office RhinAer procedure can deliver sustained, meaningful relief from chronic rhinitis ...
A Study of RhinAer Stylus for Treating Chronic Rhinitis
Post-market study to continue to evaluate the effectiveness of the RhinAer Stylus for chronic rhinitis and the effect of treatment on inflammatory biomarkers.
CTP1056 Rev C Clinical Study Protocol - RELIEF
The purpose of this study is to assess the clinical use of the RhinAer Stylus to treat tissue in the posterior nasal nerve area to improve ...
Aerin Medical | Rhinitis & Nasal Airway Obstruction Treatment
A comprehensive treatment for chronic rhinitis that provides long-lasting relief from runny nose, post-nasal drip, congestion, itching, and sneezing symptoms.
8.
ctv.veeva.com
ctv.veeva.com/study/a-study-of-rhinaer-arc-stylus-for-treating-chronic-rhinitis-reliefA Study of RhinAer ARC Stylus for Treating Chronic Rhinitis ...
Post-market study to continue to evaluate the effectiveness of the RhinAer ARC Stylus for chronic rhinitis.
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