Vivaer Stylus for Nasal Airway Obstruction
(AERWAY Trial)
Recruiting at 11 trial locations
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Aerin Medical
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Trial Summary
What is the purpose of this trial?
Post-market study to continue to evaluate the effectiveness of the Vivaer® ARC Stylus for nasal airway obstruction
Eligibility Criteria
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
Willing and able to provide informed consent
Willing and able to comply with the study protocol
You are currently looking for treatment for a blocked nose.
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Exclusion Criteria
Rhinoplasty, septoplasty, inferior turbinate reduction or other surgical nasal procedures within the past three (3) months
You have had surgery on your nasal valve before.
You need to have another nasal surgery on the same day or within 3 months after the Vivaer procedure.
See 1 more
Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Thermal treatment of submucosal tissue including cartilage in the internal nasal valve area using the Vivaer® ARC Stylus
1 day
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments at 3, 6, 12, and 24 months
24 months
Multiple visits (in-person)
Treatment Details
Interventions
- Vivaer Stylus
Trial Overview The effectiveness of the Vivaer® ARC Stylus, a non-surgical treatment for easing nasal airway blockage, is being studied in people experiencing nasal congestion. The trial continues post-market evaluation of this device's performance.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Vivaer StylusExperimental Treatment1 Intervention
Intervention: Procedure: thermal treatment of submucosal tissue including cartilage in the internal nasal valve area
Find a Clinic Near You
Who Is Running the Clinical Trial?
Aerin Medical
Lead Sponsor
Trials
13
Recruited
930+
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