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Nasal Airway Obstruction Device
Vivaer Stylus for Nasal Airway Obstruction (AERWAY Trial)
N/A
Waitlist Available
Research Sponsored by Aerin Medical
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 month
Awards & highlights
AERWAY Trial Summary
This trial will continue to monitor the effectiveness of the Vivaer® ARC Stylus, a device used to clear nasal airway obstruction.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects are not listed here, potential risks may include discomfort at the treatment site, possible short-term increase in congestion, and typical risks associated with similar minor procedures.
AERWAY Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 month
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Nasal Obstructive Symptom Evaluation (NOSE) Scores From Baseline to 3 Months
Other outcome measures
Change in Nasal Obstructive Symptom Evaluation (NOSE)Scores From Baseline to 24 Months - Analysis
Subject Reported Change in Medication Use for Nasal Obstruction Symptoms
Subject-reported Visual Analog Scale (VAS) Pain Scores in Relation to the Area Treated by the Study Procedure
AERWAY Trial Design
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vivaer Stylus
2017
N/A
~110
Find a Location
Who is running the clinical trial?
Aerin MedicalLead Sponsor
11 Previous Clinical Trials
800 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.You are currently looking for treatment for a blocked nose.Your doctor has determined that the main reason for your nasal blockage is the nasal valve, and you have responded positively to temporary measures like using nasal strips, Q-tip test, nasal stents, or Cottle Maneuver.Your NOSE score is 60 or higher at the beginning of the study.
Research Study Groups:
This trial has the following groups:- Group 1: Vivaer Stylus
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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