A Prospective, Multi-Center Non-Randomized Study to Evaluate Treatment of Nasal Airway Obstruction Using the Aerin Medical Device

Status: Completed
Location: See all (9) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Evaluation of the Aerin Medical Device used for the treatment of nasal obstruction.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 22
Maximum Age: 75
Healthy Volunteers: f
View:

• Seeking treatment for nasal obstruction and willing to undergo an office-based procedure

• Nasal Obstruction Symptom Evaluation (NOSE) score of ≥ 60 at Baseline

• 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)

Locations
United States
California
Central California Clinical Research
Fresno
Colorado
Colorado ENT and Allergy
Colorado Springs
North Carolina
Piedmont Ear, Nose and Throat Associates
Winston-salem
New Jersey
ENT and Allergy Associates, LLP
Oradell
New York
ENT and Allergy Associates, LLP
Bayside
ENT and Allergy Associates, LLP
New Hyde Park
ENT and Allergy Associates, LLP
New York
ENT and Allergy Associates, LLP
Staten Island
Texas
Ear, Nose and Throat Associates of Texas
Mckinney
Time Frame
Start Date: 2016-09-27
Completion Date: 2017-08-18
Participants
Target number of participants: 50
Treatments
Experimental: Vivaer Stylus
Intervention: Procedure: thermal treatment of submucosal tissue including cartilage in the internal nasal valve area
Sponsors
Leads: Aerin Medical

This content was sourced from clinicaltrials.gov