CompletedNot Applicable

The Vivaer Procedure for Treatment of the Septal Swell Bodies (SWELL)

United States70 participantsStarted 2021-09-14

Plain-language summary

Post-market study to access the clinical use of the Vivaer Arc Stylus to treat Septal Swell Bodies (SSB).

Who can participate

Age range

22 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Age 22 to 85 years (inclusively).
. Seeking treatment for nasal obstruction and willing to undergo an office-based procedure.
. Baseline NOSE score ≥ 55.
. Presence of SSB hypertrophy limiting visualization of the middle turbinate (MT) by more than 50%.
. Reduction in size of the SSB after application of topical decongestant on a cotton plug directly to the SSB region.
. Improvement in the symptoms of nasal obstruction after SSB decongestion suggesting that the SSB may play a role in nasal obstruction.
. Willing and able to withhold anticoagulant medications during the perioperative period (3-day window on either side).
. Willing and able to provide informed consent.

Exclusion criteria

. Rhinoplasty, septoplasty, inferior turbinate (IT) reduction, or other surgical nasal procedures within the preceding 6 months.
. Severe case of any of the following: septal deviation, turbinate hypertrophy, polyps, or ptotic nose tip believed to be the primary contributor to the participant's nasal obstruction symptoms and warranting surgical intervention.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Nasal Obstruction Symptom Evaluation (NOSE) Scale Mean Change

Timeframe: 3 months (13 weeks) visit following screening

Trial details

NCT IDNCT05099263

SponsorAerin Medical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-04-27

Results submitted2023-12-18

View on ClinicalTrials.gov More Nasal Obstruction trials