NCT03290300

Quality of Life Impact of Nasal Airway Treatment With Aerin Medical Device

A Prospective, Multi-Center, Non-Randomized Study to Evaluate the Quality of Life Impact After Treatment of Nasal Airway Obstruction Using the Aerin Medical Vivaer Stylus

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 39 (actual)
• Sponsor: Aerin Medical · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

Evaluation of long-term (5-year) quality of life after nasal airway obstruction treatment with the Aerin Vivaer Stylus

Detailed description

This is a prospective, non-randomized, multi-center follow-up study to collect long term quality of life (QOL) data on a cohort of patients who participated in the Aerin Medical TP258 study "A Prospective, Multi-Center, Non-Randomized Study to Evaluate Treatment of Nasal Airway Obstruction Using the Aerin Medical Device". The TP258 study followed subjects out to 26 weeks post-procedure. This QOL study will collect data at 12, 18, 24, 36, 48 and 60 months post-procedure.

Conditions

• Nasal Obstruction

Interventions

Type	Name	Description
DEVICE	Vivaer Stylus	Previous nasal obstruction treatment with the Aerin Medical Vivaer Stylus

Timeline

• Start date: 2017-10-30
• Primary completion: 2022-07-09
• Completion: 2022-07-09
• First posted: 2017-09-21
• Last updated: 2024-02-15
• Results posted: 2019-08-19

Locations

8 sites across 1 country: United States