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NCT04277507 · ClinicalTrials.gov registry record · NA
Study of the AERin Medical Vivaer® ARC Stylus for Nasal AirWAY Obstruction
A NA study of Nasal Obstruction, sponsored by Aerin Medical.
- Completed
- Registry status
- NA
- Development phase
- 122
- Enrollment target
- 10
- Study locations
NCT04277507: Completed NA study of Nasal Obstruction, sponsored by Aerin Medical.
NCT04277507 is a NA study of Nasal Obstruction that has completed, run by Aerin Medical. The registered enrollment target is 122 participants, below the 136-participant average among 4 other Nasal Obstruction trials with a reported enrollment target (10% lower). The trial reports 10 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04277507, a NA study of Nasal Obstruction, has completed, sponsored by Aerin Medical.
- COMPLETED
- Registry status
- NA
- Development phase
- 122 participants
- Enrollment target
- 10
- Study locations
Study Summary
Post-market study to continue to evaluate the effectiveness of the Vivaer® ARC Stylus for nasal airway obstruction
Primary Outcome
Mean change in NOSE score from Baseline to 3 months.Scores may range from the best score of 0, meaning no nasal obstructive symptoms to the worst score of 100, meaning severe nasal obstructive symptoms.
Conditions Studied
Interventions
- DEVICE Vivaer Stylus
Study Locations (10)
Florida
- ENT Associates of South Florida - Boca Raton
- ENT Associates of South Florida - Plantation
Texas
- UT Physicians Otorhinolaryngology - Texas Medical Center - Houston
- ENT Associates of Texas - McKinney
Alabama
- Alabama Nasal and Sinus Center - Birmingham
Arizona
- Arizona Desert ENT Specialists - Goodyear
California
- Sacramento ENT - Roseville
Illinois
- Chicago Nasal and Sinus Center - Chicago
Louisiana
- Baton Rouge General / Sinus and Nasal Specialists of Louisiana - Baton Rouge
New Jersey
- Advocare Aroesty ENT Associates - Mount Arlington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 122 participants |
| Start Date | 2020-02-07 |
| Est. Completion | 2024-10-11 |
| Phase | NA |
What the finished NCT04277507 record still lists
NCT04277507 is an interventional study that assigns participants to a tested intervention. The registered 122 participants enrollment target is mid-sized for trials with a published cap, below the 136-participant average among 4 other Nasal Obstruction trials with a reported enrollment target (10% lower).
The record links to 1 condition, with Nasal Obstruction appearing as the primary indexed condition, and to 1 intervention - of which Vivaer Stylus is the first listed.
NCT04277507 lists 10 locations in 8 states (Florida, Texas, Alabama).
Frequently Asked Questions
What is clinical trial NCT04277507 about?
NCT04277507 is a clinical study titled "Study of the AERin Medical Vivaer® ARC Stylus for Nasal AirWAY Obstruction". Post-market study to continue to evaluate the effectiveness of the Vivaer® ARC Stylus for nasal airway obstruction
What is the current status of trial NCT04277507?
This trial is currently completed. It is a NA study. The enrollment target is 122 participants. The study started on 2020-02-07. Estimated completion is 2024-10-11.
What conditions does trial NCT04277507 study?
This clinical trial studies the following conditions: Nasal Obstruction.
What interventions are being tested in trial NCT04277507?
The interventions under investigation include: Vivaer Stylus (DEVICE).
Who is sponsoring clinical trial NCT04277507?
This trial is sponsored by Aerin Medical, which has 14 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04277507 being conducted?
This trial has 10 study locations across Alabama, Arizona, California, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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