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Study of the AERin Medical Vivaer® ARC Stylus for Nasal AirWAY Obstruction

Sponsored by Aerin Medical

About this trial

Last updated 2 years ago

Study ID

TP900

Status

Active, not recruiting

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended a year ago

What is this trial about?

Post-market study to continue to evaluate the effectiveness of the Vivaer® ARC Stylus for nasal airway obstruction

What are the participation requirements?

Yes

Inclusion Criteria

1. Age 18 or older

2. Willing and able to provide informed consent

3. Willing and able to comply with the study protocol

4. Seeking treatment for nasal obstruction

5. NOSE score of ≥ 60 at Baseline

6. Nasal valve is a primary or significant contributor to the subject's nasal obstruction as determined by the study investigator (based on clinical presentation, physical examination, nasal endoscopy, etc.) and the subject has a positive response to any of the following temporary measures (based on patient history or office exam):

- Use of external nasal dilator strips (e.g., Breathe Right Strips)
- Q-Tip test (manual intranasal lateralization)
- Use of nasal stents
- Cottle Maneuver (manual lateral retraction of the cheek)
No

Exclusion Criteria

1. Prior surgical treatment of the nasal valve

2. Rhinoplasty, septoplasty, inferior turbinate reduction or other surgical nasal procedures within the past three (3) months

3. Anatomy that requires an adjunctive surgical nasal procedure on the same day or 3 months after the Vivaer procedure

4. Medical conditions which in the opinion of the treating physician would predispose the subject to poor wound healing or increased surgical risk.

Locations

Location

Status