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).

Age range22 Years – 85 Years

SexALL

See this in plain English?

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

✓. 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.

✕. 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.
✕. Any adjunctive surgical nasal procedure planned on the same day or within 3 months after the Vivaer procedure.
✕. Known or suspected allergies or contraindications for any general or local anesthetic agents.
✕. Known or suspected to be pregnant or is lactating.
✕. Participating in another clinical research study.
✕. Other medical conditions which in the opinion of the investigator would predispose the participant to poor wound healing or increased surgical risk, or poor compliance with the requirements of the study.
✕. Known or suspected regular use of oxymetazoline (Afrin) nasal decongestant or oral steroids.

Nasal Obstruction Symptom Evaluation (NOSE) Scale Mean Change

Timeframe: 3 months (13 weeks) visit following screening

NCT IDNCT05099263

SponsorAerin Medical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-04-27

Results submitted2023-12-18

Who can participate

Age range22 Years – 85 Years

SexALL

See this in plain English?

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

✓. 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.

✕. 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.
✕. Any adjunctive surgical nasal procedure planned on the same day or within 3 months after the Vivaer procedure.
✕. Known or suspected allergies or contraindications for any general or local anesthetic agents.
✕. Known or suspected to be pregnant or is lactating.
✕. Participating in another clinical research study.
✕. Other medical conditions which in the opinion of the investigator would predispose the participant to poor wound healing or increased surgical risk, or poor compliance with the requirements of the study.
✕. Known or suspected regular use of oxymetazoline (Afrin) nasal decongestant or oral steroids.