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Vivaer Procedure for Nasal Congestion (SWELL Trial)
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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
Presence of SSB hypertrophy limiting visualization of the middle turbinate (MT) by more than 50%
Age 22 to 85 years (inclusively)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months (13 weeks) visit following baseline
Awards & highlights
SWELL Trial Summary
This trial will study the use of the Vivaer Arc Stylus to treat Septal Swell Bodies. The study will assess the safety and effectiveness of the device.
Who is the study for?
This trial is for adults aged 22 to 85 with nasal congestion, specifically due to swollen septal bodies. Participants must have a NOSE score of at least 55, indicating significant nasal blockage, and be able to stop blood thinners around the procedure. They should not have had recent nasal surgery or plan any within 3 months after this treatment.Check my eligibility
What is being tested?
The study tests the Vivaer Arc Stylus device's effectiveness in treating Septal Swell Bodies (SSB) causing nasal obstruction. It's an office-based procedure evaluated post-market, meaning it’s already approved but further studied for clinical use outcomes.See study design
What are the potential side effects?
Potential side effects are not explicitly listed here but may include discomfort from the procedure, risks associated with stopping anticoagulants temporarily, and typical surgical risks like poor wound healing or infection.
SWELL Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
More than half of my middle nasal passage is blocked.
Select...
I am between 22 and 85 years old.
SWELL Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months (13 weeks) visit following baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months (13 weeks) visit following baseline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Nasal Obstruction Symptom Evaluation (NOSE) Scale Mean Change
Secondary outcome measures
Device Related Adverse Events
Responder Percent
SWELL Trial Design
1Treatment groups
Experimental Treatment
Group I: Vivaer ProcedureExperimental Treatment1 Intervention
The Vivaer procedure will be performed in the study clinic using the Vivaer ARC Stylus and Aerin Console. The Vivaer ARC 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 undergo bilateral treatment of the nasal airway in a single study procedure session. Each side of the nose will be treated as follows:
• Two (2) to six (6) nonoverlapping applications of RF energy are performed at the SSB per nostril.
The default treatment settings will be used for the study: temperature 60 C, power 4 watts, treatment time 18 seconds, and cooling time 12 seconds. No repeat ("touch up") procedures will be permitted after the initial procedure through the end of the study (36 months).
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Who is running the clinical trial?
Aerin MedicalLead Sponsor
11 Previous Clinical Trials
852 Total Patients Enrolled
Anais LabordeStudy DirectorAerin Medical
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a severe nasal blockage due to a deviated septum, enlarged turbinates, polyps, or drooping nose tip needing surgery.I can stop taking blood thinners around the time of my surgery.My swollen sinus became smaller after using a decongestant.You have other health issues that could make it harder for your body to heal from surgery or increase the risk of complications.More than half of my middle nasal passage is blocked.I have not had nose surgery in the last 6 months.I regularly use Afrin nasal spray or take oral steroids.I am between 22 and 85 years old.I am allergic to some anesthetics.If you are part of the CT substudy, you cannot have a serious sinus condition shown on a CT scan.My nasal blockage got better after a specific nasal test.I plan to have or had nasal surgery around the same time as the Vivaer procedure.You are willing and able to comply with the study protocol.Your NOSE score is 55 or higher before starting the study.I am between 22 and 85 years old.I can stop taking blood thinners around the time of my surgery.Your initial NOSE score is 55 or higher.I want treatment for my blocked nose and am okay with an office procedure.
Research Study Groups:
This trial has the following groups:- Group 1: Vivaer Procedure
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.
Is this scientific inquiry open to participants aged 50 years and above?
"This clinical trial stipulates that enrollees must be between 22 and 85 years of age, as per the inclusion criteria."
Answered by AI
In which locations is this trial currently being conducted?
"People who are interested in participating in this trial can enrol at the Chicago Nasal and Sinus Center, Rush University Cincinnati Ohio or the University of Cincinnati College of Medicine Colorado Springs as well as 9 other sites."
Answered by AI
Who does the research team deem ideal for participation in this experiment?
"This medical trial is searching for 70 volunteers between the ages of 22 and 85 who suffer from nasal obstruction. To be accepted, applicants must have a NOSE score greater than 55, agree to cease taking anticoagulants during surgery (3 days before and after), and adhere to other requirements outlined in the study protocol."
Answered by AI
Is this investigation now accepting participants?
"The clinicaltrials.gov website reveals that this research project is not currently looking for patients, despite being initially posted on the 14th of September 2021 and last updated on June 7th 2022. However, there exist 14 other medical studies actively recruiting subjects at present."
Answered by AI
Who else is applying?
What state do they live in?
Nevada
How old are they?
65+
18 - 65
What site did they apply to?
Colorado Otolaryngology Associates LLC
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How responsive is this trial?
Typically responds via
Email
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