Vivaer Stylus for Nasal Airway Obstruction
(AERWAY Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test the effectiveness of the Vivaer® ARC Stylus, a device for treating nasal airway obstruction. The procedure uses thermal treatment, which involves heat, to open the nasal passages, focusing on the internal nasal valve area. Individuals with significant nasal blockage, especially those who experience improvement with temporary measures like nasal strips or the Cottle Maneuver (pulling the cheek to open the nasal passage), might be suitable candidates.
As an unphased trial, this study provides a unique opportunity to explore innovative treatment options for nasal airway obstruction.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
What prior data suggests that the Vivaer Stylus is safe for nasal airway obstruction?
Research has shown that the Vivaer Stylus is generally safe for people. This tool, used in nose surgeries, has received FDA approval, indicating it meets safety standards for procedures that improve nasal breathing.
Studies have found that the Vivaer procedure is non-invasive, requiring no large incisions. This typically results in fewer complications compared to more invasive surgeries. Patients have reported positive outcomes, experiencing lasting relief from nasal blockage without major side effects.
Overall, the treatment is well-tolerated, and serious adverse events have not been commonly reported. This supports confidence in its safety for treating nasal airway obstruction.12345Why are researchers excited about this trial?
The Vivaer Stylus is unique because it uses thermal treatment to target submucosal tissue, including cartilage, in the internal nasal valve area. Unlike traditional treatments for nasal airway obstruction, like medications or surgical procedures, this method offers a less invasive approach. Researchers are excited because this technique could provide lasting relief with minimal downtime, offering a new option for those who have not found success with current treatments.
What evidence suggests that the Vivaer Stylus is effective for nasal airway obstruction?
Studies have shown that the Vivaer Stylus, which participants in this trial will receive, effectively treats blocked nasal airways. Specifically, 97.2% of patients experienced a significant and lasting reduction in symptoms over two years. This treatment uses controlled heat to open nasal passages by reshaping the tissue in the nasal area. Patients reported ongoing improvement in their ability to breathe through their noses, suggesting that Vivaer can provide long-term relief for those struggling with nasal blockage.23467
Are You a Good Fit for This Trial?
This trial is for adults over 18 who have nasal obstruction, where the nasal valve plays a significant role. Participants must be willing to follow the study rules and have had positive responses to temporary measures like nasal strips or manual tests. Those with recent nose surgeries or conditions affecting wound healing can't join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Thermal treatment of submucosal tissue including cartilage in the internal nasal valve area using the Vivaer® ARC Stylus
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments at 3, 6, 12, and 24 months
What Are the Treatments Tested in This Trial?
Interventions
- Vivaer Stylus
Find a Clinic Near You
Who Is Running the Clinical Trial?
Aerin Medical
Lead Sponsor