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NCT05099263 · ClinicalTrials.gov registry record · NA
The Vivaer Procedure for Treatment of the Septal Swell Bodies (SWELL)
A NA study, sponsored by Aerin Medical.
- Completed
- Registry status
- NA
- Development phase
- 70
- Enrollment target
NCT05099263: Completed NA study, sponsored by Aerin Medical.
NCT05099263 is a NA study that has completed, run by Aerin Medical. The registered enrollment target is 70 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05099263, a NA study, has completed, sponsored by Aerin Medical.
- COMPLETED
- Registry status
- NA
- Development phase
- 70 participants
- Enrollment target
Study Summary
Post-market study to access the clinical use of the Vivaer Arc Stylus to treat Septal Swell Bodies (SSB).
Primary Outcome
The primary endpoint is improvement in self-reported Nasal Obstruction Symptom Evaluation (NOSE) Scale score from baseline recorded at the screening evaluation to 13 weeks after the procedure. The NOSE Scale is a validated disease-specific health status instrument used by clinicians to measure the outcome of participants treated for nasal obstruction.43 The NOSE Scale consists of 5 items, each scored using a 5-point Likert scale to make a total score range of 0 through 100, where higher scores i
Interventions
- DEVICE Vivaer Arc Stylus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2021-09-14 |
| Est. Completion | 2024-10-16 |
| Phase | NA |
What the finished NCT05099263 record still lists
NCT05099263 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which Vivaer Arc Stylus is the first listed.
NCT05099263 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05099263 about?
NCT05099263 is a clinical study titled "The Vivaer Procedure for Treatment of the Septal Swell Bodies (SWELL)". Post-market study to access the clinical use of the Vivaer Arc Stylus to treat Septal Swell Bodies (SSB).
What is the current status of trial NCT05099263?
This trial is currently completed. It is a NA study. The enrollment target is 70 participants. The study started on 2021-09-14. Estimated completion is 2024-10-16.
What interventions are being tested in trial NCT05099263?
The interventions under investigation include: Vivaer Arc Stylus (DEVICE).
Who is sponsoring clinical trial NCT05099263?
This trial is sponsored by Aerin Medical, which has 14 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05099263's enrollment target sits among peer trials
70 1103rd of 2000 higher than 868 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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