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NCT04549545 · ClinicalTrials.gov registry record · NA
Vivaer® Procedure for Treatment of Nasal Airway Obstruction Study
A NA study, sponsored by Aerin Medical.
- Completed
- Registry status
- NA
- Development phase
- 119
- Enrollment target
NCT04549545: Completed NA study, sponsored by Aerin Medical.
NCT04549545 is a NA study that has completed, run by Aerin Medical. The registered enrollment target is 119 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04549545, a NA study, has completed, sponsored by Aerin Medical.
- COMPLETED
- Registry status
- NA
- Development phase
- 119 participants
- Enrollment target
Study Summary
The purpose of this study is to compare the Vivaer procedure with radiofrequency (RF) energy to sham procedure for treatment of nasal airway obstruction (NAO).
Primary Outcome
The Nasal Obstruction Symptom Evaluation (NOSE) Scale is a patient self-reported questionnaire consisting of 5 symptoms of nasal obstruction: nasal congestion, nasal blockage, trouble breathing, trouble sleeping, and getting enough air during exercise. Patients will report over the past 1 month how much the symptoms have been a problem. Total score ranges from 0 to 100, where higher scores indicate worse obstruction. Severity of symptoms can be classified as mild (range, 5-25), moderate (range,
Interventions
- DEVICE Sham
- DEVICE Vivaer ARC Stylus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 119 participants |
| Start Date | 2020-08-12 |
| Est. Completion | 2025-03-04 |
| Phase | NA |
What the finished NCT04549545 record still lists
NCT04549545 is an interventional study that assigns participants to a tested intervention. The registered 119 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which Sham is the first listed.
NCT04549545 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04549545 about?
NCT04549545 is a clinical study titled "Vivaer® Procedure for Treatment of Nasal Airway Obstruction Study". The purpose of this study is to compare the Vivaer procedure with radiofrequency (RF) energy to sham procedure for treatment of nasal airway obstruction (NAO).
What is the current status of trial NCT04549545?
This trial is currently completed. It is a NA study. The enrollment target is 119 participants. The study started on 2020-08-12. Estimated completion is 2025-03-04.
What interventions are being tested in trial NCT04549545?
The interventions under investigation include: Sham (DEVICE), Vivaer ARC Stylus (DEVICE).
Who is sponsoring clinical trial NCT04549545?
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 NCT04549545's enrollment target sits among peer trials
119 803rd of 2000 higher than 1,198 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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