NCT03156270

Treatment Outcome Using Vivaer Stylus to Treat Nasal Airway Obstruction

A Prospective, Non-Randomized Study to Evaluate Treatment Outcome of Nasal Airway Obstruction Using the Aerin Medical Vivaer™ Stylus

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Aerin Medical · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates subjective and objective measures of treatment outcome after using the Aerin Medical Vivaer™ Stylus to treat nasal obstruction

Detailed description

This is a non-significant risk, prospective, non-randomized study to evaluate subjective and objective measures of nasal obstruction both before and after treatment with the Vivaer Stylus. The Stylus is used to deliver radiofrequency (RF) energy to the nasal valve area to improve symptoms in those diagnosed with nasal airway obstruction.

Conditions

• Nasal Obstruction

Interventions

Type	Name	Description
DEVICE	Vivaer Stylus	Stylus used to deliver low-power, temperature-controlled, radiofrequency energy to the tissues of the internal nasal valve area

Timeline

• Start date: 2017-09-19
• Primary completion: 2019-07-12
• Completion: 2019-08-06
• First posted: 2017-05-17
• Last updated: 2021-06-16
• Results posted: 2021-06-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study